Johnson & Johnson (J & J) and Abbott, as well as the PhRMA, BIO and AdvaMed industry group presented their priorities for the US Food and Drug Administration's (FDA) call to amend, repeal or replace regulations , according to comments Thursday on the register.
J & J have compiled a list of seven priorities that have been tabled for both CDER and CDRH, including reforms to simplify the way in which information from manufacturers who are not on a product label are disclosed; approval allow for changes to a label without FDA clearance, reducing conflicts of interest for FDA advisory committees (which PhRMA had also requested) and increasing the use of electronic labeling rather than paper.
J & J is also reviewing the FDA's decision to pause a voluntary quality data reporting program via an FDA portal after the industry has called on the agency to take the break.
"We are in agreement with the FDA that manufacturers of quality data to collect and analyze, but collects each company and analyze the data in its own way and adhering to a one-size-fits-all approach requires changes in heavy process. Cosmetic Act authorizes the FDA to require companies to collect data and submit the prescribed formats. We are compliant with the current pause in the additional input program from stakeholders and suggest that manufacturers should not enter to present data quality and statistics these data must be available for review during inspections, "says the comment.
PhRMA also called for changes in the FDA's guidelines on human factors research in the comments of the CDRH, while BIO called for regulatory changes for genetically modified animals.
Mutual approvals and inspections
J & J also suggests that mutual FDA approval of medical devices with the EU allows a medical device "class III ... save lives of vanguard additional data would be postmarketing place to access the patient's treatment options While the commitment is maintained The FDA requirements for Subparts B and C of 21 CFR 814 must be revised to reflect this approach. "
Abbott is appealing to the FDA to withdraw a proposed rule on the electronic submission of labels for certain home appliances that, in its opinion, is "superfluous because the labeling of devices is necessary to accompany medical devices used in distribution commercial. widely available to users and many home appliance manufacturers provide product labeling information on their websites. "
The AdvaMed group of Device Industry made 19 recommendations, covering everything from revisions to the use of symbols in the labeling rule, asking the FDA to consider a paper assessment rather than a prior on-site approval. .
"The increased use of evaluation by the production section of an LDC would save time. Approval inspections are intensive in terms of time and resources, "said the group, suggesting that a change could save $ 10 million.
Sunday, February 11, 2018
Monday, February 5, 2018
Falsified Medicines: EC Report Finds Inconsistent Penalties Throughout the EU
A recent European Commission (EC) report shows that although all EU Member States have implemented laws in accordance with the Falsified Medicines Directive, sanctions for violating these laws vary considerably from one country to another. country to another.
"Sanctions are only effective if they are properly implemented and I urge all EU countries to ensure that criminals who falsify drugs are punished," said Vytenis Andriukaitis, European Commissioner for Health and food security. ensure that criminals catch counterfeit drugs are punished.
According to the report, the maximum imprisonment penalty for falsifying a drug of only one year varies between Sweden, Finland and Greece at age 15 in Austria, Slovenia and Slovakia.
The maximum penalties for the counterfeiting of a medicine range from € 4,300 in Lithuania to € 1 million in Spain. In the United Kingdom, there is no maximum for such fines.
Similarly, maximum prison sentences and misconduct penalties for active substances and excipients vary considerably from one Member State to another.
In addition, the specification differs from what has been criminalized from one Member State to another. For example, Latvia sanctions drug falsification resulting in bodily injury or death, while most Member States criminalize falsification "without the need to prove that the product is dangerous to health" .
The report also notes that it is "difficult to measure the effectiveness of specific national sanctions because of a lack of comprehensive data on incidents in the Member States".
However, experts consulted before the report told the EC that the sanctions "had at least one effect on reducing the presence of counterfeit drugs in the legal distribution chain," but described the administrative sanctions as the most effective deterrent.
But with regard to the sale of illegal drugs, the experts found that criminal sanctions were a more effective deterrent.
As such, the report recommends that Member States introduce additional administrative and criminal penalties for falsified medicines and request countries to reserve sufficient resources to maintain these sanctions.
"Sanctions are only effective if they are properly implemented and I urge all EU countries to ensure that criminals who falsify drugs are punished," said Vytenis Andriukaitis, European Commissioner for Health and food security. ensure that criminals catch counterfeit drugs are punished.
According to the report, the maximum imprisonment penalty for falsifying a drug of only one year varies between Sweden, Finland and Greece at age 15 in Austria, Slovenia and Slovakia.
The maximum penalties for the counterfeiting of a medicine range from € 4,300 in Lithuania to € 1 million in Spain. In the United Kingdom, there is no maximum for such fines.
Similarly, maximum prison sentences and misconduct penalties for active substances and excipients vary considerably from one Member State to another.
In addition, the specification differs from what has been criminalized from one Member State to another. For example, Latvia sanctions drug falsification resulting in bodily injury or death, while most Member States criminalize falsification "without the need to prove that the product is dangerous to health" .
The report also notes that it is "difficult to measure the effectiveness of specific national sanctions because of a lack of comprehensive data on incidents in the Member States".
However, experts consulted before the report told the EC that the sanctions "had at least one effect on reducing the presence of counterfeit drugs in the legal distribution chain," but described the administrative sanctions as the most effective deterrent.
But with regard to the sale of illegal drugs, the experts found that criminal sanctions were a more effective deterrent.
As such, the report recommends that Member States introduce additional administrative and criminal penalties for falsified medicines and request countries to reserve sufficient resources to maintain these sanctions.
Sunday, January 28, 2018
FDA Publishes First Performance Metrics for Third Party 510(k) Reviews
The US Food and Drug Administration (FDA) on Friday published the first of its quarterly performance reports for accredited third party reviewers for certain medical device submissions.
Background
FDA's third party accredited persons program was created by the 1997 FDA Modernization Act (FDAMA) as a means of making the review process for certain low-risk devices submitted under a 510(k) more timely and efficient.
Under the program, device makers can submit 510(k)s for eligible devices to accredited third parties that conduct the primary review of the submission before forwarding their recommendation to FDA, which makes a final determination on the recommendation within 30 days.
There are currently seven accredited third party reviewed under the program based in the US, China and Norway.
Performance Metrics
While FDA's third party accredited persons program has been operational for roughly two decades, the agency had not released performance data for individual third party reviewers until this year, after committing to do so in the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).
However, under MDUFA IV, FDA only agreed to publish performance data for third party reviewers that have completed a minimum of five reviews during the reporting period, which at the time of the agency's first report includes just one third party reviewer: Regulatory Technology Services (RTS).
The report itself features a box plot detailing the performance of the individual third party reviewers for six different metrics:
In total, FDA says there have been 18 third party 510(k) submissions in FY2018, eight of which have been completed and found substantially equivalent to a predicate device, and ten of which are still pending a final decision by FDA.
Of the ten pending decisions, nine are still within the 30-day window for FDA to issue a determination, while one has been pending for more than 30 days.
For the third party reviews themselves, FDA says the average total time to decision from the time a third party reviewer receives a submission to when FDA issues its final determination is 80 days, with an interquartile range of 52 to 94 days and the longest review taking 172 days.
Background
FDA's third party accredited persons program was created by the 1997 FDA Modernization Act (FDAMA) as a means of making the review process for certain low-risk devices submitted under a 510(k) more timely and efficient.
Under the program, device makers can submit 510(k)s for eligible devices to accredited third parties that conduct the primary review of the submission before forwarding their recommendation to FDA, which makes a final determination on the recommendation within 30 days.
There are currently seven accredited third party reviewed under the program based in the US, China and Norway.
Performance Metrics
While FDA's third party accredited persons program has been operational for roughly two decades, the agency had not released performance data for individual third party reviewers until this year, after committing to do so in the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).
However, under MDUFA IV, FDA only agreed to publish performance data for third party reviewers that have completed a minimum of five reviews during the reporting period, which at the time of the agency's first report includes just one third party reviewer: Regulatory Technology Services (RTS).
The report itself features a box plot detailing the performance of the individual third party reviewers for six different metrics:
- Initial third party review time
- Third party hold time
- Total third party review time
- Total FDA review time
- Total time to decision from FDA
- Total time to decision from third party receipt
In total, FDA says there have been 18 third party 510(k) submissions in FY2018, eight of which have been completed and found substantially equivalent to a predicate device, and ten of which are still pending a final decision by FDA.
Of the ten pending decisions, nine are still within the 30-day window for FDA to issue a determination, while one has been pending for more than 30 days.
For the third party reviews themselves, FDA says the average total time to decision from the time a third party reviewer receives a submission to when FDA issues its final determination is 80 days, with an interquartile range of 52 to 94 days and the longest review taking 172 days.
Sunday, January 14, 2018
FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation
After examining the cause of the faulty lead test of four of Magellan Diagnostics LeadCare test systems last May, the Food and Drug Administration (FDA) warned Becton Dickinson (BD) on Thursday that it has not submitted a new lead test. 510 (k) for changes in his blood collection tubes.
At the beginning of the study, Jeffrey Shuren, director of the Center for Apparatus and Radiological Health (CDRH), said that the agency tried to determine the cause of the inaccurate test results, but still did not know these problems because of differences in blood. samples are collected, tubes are used to hold blood or a change in the way samples are processed.
As part of the investigation, the FDA inspected BD facilities in Franklin Lakes, New Jersey, where it produces Vacutainer blood collection tubes for three weeks in May and June.
"Our inspection has shown that BD has violated the law by making major changes to certain devices ... without notifying the FDA and not following good manufacturing practices," said Donald St. Pierre, Deputy Director of Evaluation. new products on CDRH. The FDA also stated that BD had not investigated a 2015 Magellan complaint regarding "observed negative bias" in test results with Magellan's LeadCare test systems when using Vacutainer tubes.
"Your company did not record this information in the complaints system, did not evaluate the complaint to determine whether this was a reportable event, or started an investigation into the complaint," the FDA wrote.
Although the FDA has stated that changes in the composition of rubber stoppers used with Vacutainer tubes may cause new interference with laboratory tests and lead to biased results, the agency said it was uncertain.
In a statement released on Friday, Richard Byrd, president of BD's pre-analytical systems, said the company was working with the FDA and thought the company was responding fully to the agency's inspection observations.
Update on BD spraying
On Friday, the FDA also announced that BD has stopped using rubber stoppers in its syringes, which reduces the power of the drug.
In September 2015, the FDA warned health professionals against the use of BD general-purpose syringes with compounded or reconditioned drugs stored in syringes due to the potential of drugs that interact with the rubber stopper in the syringe.
Although the FDA has approved approved syringes for general aspiration and injection of fluids, they are not authorized to be used as closed container storage systems for pharmaceuticals.
Now the FDA has declared that BD has stopped the rubber stopping material with regard to the power loss of the medicine and has returned with a rubber stopper used in other syringes.
Healthcare professionals should contact BD to determine if specific batches of syringes contain the new caps.
At the beginning of the study, Jeffrey Shuren, director of the Center for Apparatus and Radiological Health (CDRH), said that the agency tried to determine the cause of the inaccurate test results, but still did not know these problems because of differences in blood. samples are collected, tubes are used to hold blood or a change in the way samples are processed.
As part of the investigation, the FDA inspected BD facilities in Franklin Lakes, New Jersey, where it produces Vacutainer blood collection tubes for three weeks in May and June.
"Our inspection has shown that BD has violated the law by making major changes to certain devices ... without notifying the FDA and not following good manufacturing practices," said Donald St. Pierre, Deputy Director of Evaluation. new products on CDRH. The FDA also stated that BD had not investigated a 2015 Magellan complaint regarding "observed negative bias" in test results with Magellan's LeadCare test systems when using Vacutainer tubes.
"Your company did not record this information in the complaints system, did not evaluate the complaint to determine whether this was a reportable event, or started an investigation into the complaint," the FDA wrote.
Although the FDA has stated that changes in the composition of rubber stoppers used with Vacutainer tubes may cause new interference with laboratory tests and lead to biased results, the agency said it was uncertain.
In a statement released on Friday, Richard Byrd, president of BD's pre-analytical systems, said the company was working with the FDA and thought the company was responding fully to the agency's inspection observations.
Update on BD spraying
On Friday, the FDA also announced that BD has stopped using rubber stoppers in its syringes, which reduces the power of the drug.
In September 2015, the FDA warned health professionals against the use of BD general-purpose syringes with compounded or reconditioned drugs stored in syringes due to the potential of drugs that interact with the rubber stopper in the syringe.
Although the FDA has approved approved syringes for general aspiration and injection of fluids, they are not authorized to be used as closed container storage systems for pharmaceuticals.
Now the FDA has declared that BD has stopped the rubber stopping material with regard to the power loss of the medicine and has returned with a rubber stopper used in other syringes.
Healthcare professionals should contact BD to determine if specific batches of syringes contain the new caps.
Thursday, January 4, 2018
OPDP Letters: FDA Closes Out 2017 With Record Low
In the last days of 2017, the Office of Prescription Drug Promotion (OPDP) of the US Food and Drug Administration. UU (FDA) has sent a warning letter to over-the-counter pharmacist Avanthi, Inc. to omit risk information on a panel for the Lomaira weight loss drug (Phentermine hydrochloride, USP).
The warning letter brings to four the total number of compliance letters issued by the OPDP in 2017 (three warning letters and one untitled letter), a historical minimum for the agency.
While the number of letters sent each year by the OPDP has steadily declined since the late 1990s, while the office regularly published more than 100 letters per year, 2017 is the second time that the office has published fewer than 10 letters per year. 'action.
In 2015, the OPDP issued only nine action cards (two warning letters and seven untitled letters) and in 2016 the office issued 11 action cards (three warning letters and eight untitled letters). ) after a series of six letters the last weeks of the year.
Warning letter
According to the FDA, a panel sponsored by Avanthi, which appeared in the exhibition halls of the 2017 annual meetings of the Endocrine Society and the American College of Cardiology, failed to mention the risks of Lomaira.
The panel, which advocates "flexible dosing options" and makes other promotional statements such as "The power of three", does not mention any possible side effects, contraindications or warnings of the drug, such as the risk of abuse and dependence.
"By omitting the risks associated with Lomaira, including serious and potentially fatal risks, panel fairs provide material information about the consequences that may result from the use of the drug and create a misleading impression of the safety of the drug", wrote the FDA.
The FDA also notes that Lomaira is only indicated in the short term in patients with a body mass index of 30 kg / m2 or greater than or equal to 27 kg / m2, with other risk factors such as controlled hypertension , diabetes or hyperlipidemia.
In response, the FDA is asking Avanthi to stop labeling Lomaira and provide an action plan to broadcast "true, non-misleading and complete remedial messages" to the audiences who received the promotional material.
The warning letter brings to four the total number of compliance letters issued by the OPDP in 2017 (three warning letters and one untitled letter), a historical minimum for the agency.
While the number of letters sent each year by the OPDP has steadily declined since the late 1990s, while the office regularly published more than 100 letters per year, 2017 is the second time that the office has published fewer than 10 letters per year. 'action.
In 2015, the OPDP issued only nine action cards (two warning letters and seven untitled letters) and in 2016 the office issued 11 action cards (three warning letters and eight untitled letters). ) after a series of six letters the last weeks of the year.
Warning letter
According to the FDA, a panel sponsored by Avanthi, which appeared in the exhibition halls of the 2017 annual meetings of the Endocrine Society and the American College of Cardiology, failed to mention the risks of Lomaira.
The panel, which advocates "flexible dosing options" and makes other promotional statements such as "The power of three", does not mention any possible side effects, contraindications or warnings of the drug, such as the risk of abuse and dependence.
"By omitting the risks associated with Lomaira, including serious and potentially fatal risks, panel fairs provide material information about the consequences that may result from the use of the drug and create a misleading impression of the safety of the drug", wrote the FDA.
The FDA also notes that Lomaira is only indicated in the short term in patients with a body mass index of 30 kg / m2 or greater than or equal to 27 kg / m2, with other risk factors such as controlled hypertension , diabetes or hyperlipidemia.
In response, the FDA is asking Avanthi to stop labeling Lomaira and provide an action plan to broadcast "true, non-misleading and complete remedial messages" to the audiences who received the promotional material.
OPDP Letters: FDA Closes Out 2017 With Record Low
In the last days of 2017, the Office of Prescription Drug Promotion (OPDP) of the US Food and Drug Administration. UU (FDA) has sent a warning letter to over-the-counter pharmacist Avanthi, Inc. to omit risk information on a panel for the Lomaira weight loss drug (Phentermine hydrochloride, USP).
The warning letter brings to four the total number of compliance letters issued by the OPDP in 2017 (three warning letters and one untitled letter), a historical minimum for the agency.
While the number of letters sent each year by the OPDP has steadily declined since the late 1990s, while the office regularly published more than 100 letters per year, 2017 is the second time that the office has published fewer than 10 letters per year. 'action.
In 2015, the OPDP issued only nine action cards (two warning letters and seven untitled letters) and in 2016 the office issued 11 action cards (three warning letters and eight untitled letters). ) after a series of six letters the last weeks of the year.
Warning letter
According to the FDA, a panel sponsored by Avanthi, which appeared in the exhibition halls of the 2017 annual meetings of the Endocrine Society and the American College of Cardiology, failed to mention the risks of Lomaira.
The panel, which advocates "flexible dosing options" and makes other promotional statements such as "The power of three", does not mention any possible side effects, contraindications or warnings of the drug, such as the risk of abuse and dependence.
"By omitting the risks associated with Lomaira, including serious and potentially fatal risks, panel fairs provide material information about the consequences that may result from the use of the drug and create a misleading impression of the safety of the drug", wrote the FDA.
The FDA also notes that Lomaira is only indicated in the short term in patients with a body mass index of 30 kg / m2 or greater than or equal to 27 kg / m2, with other risk factors such as controlled hypertension , diabetes or hyperlipidemia.
In response, the FDA is asking Avanthi to stop labeling Lomaira and provide an action plan to broadcast "true, non-misleading and complete remedial messages" to the audiences who received the promotional material.
The warning letter brings to four the total number of compliance letters issued by the OPDP in 2017 (three warning letters and one untitled letter), a historical minimum for the agency.
While the number of letters sent each year by the OPDP has steadily declined since the late 1990s, while the office regularly published more than 100 letters per year, 2017 is the second time that the office has published fewer than 10 letters per year. 'action.
In 2015, the OPDP issued only nine action cards (two warning letters and seven untitled letters) and in 2016 the office issued 11 action cards (three warning letters and eight untitled letters). ) after a series of six letters the last weeks of the year.
Warning letter
According to the FDA, a panel sponsored by Avanthi, which appeared in the exhibition halls of the 2017 annual meetings of the Endocrine Society and the American College of Cardiology, failed to mention the risks of Lomaira.
The panel, which advocates "flexible dosing options" and makes other promotional statements such as "The power of three", does not mention any possible side effects, contraindications or warnings of the drug, such as the risk of abuse and dependence.
"By omitting the risks associated with Lomaira, including serious and potentially fatal risks, panel fairs provide material information about the consequences that may result from the use of the drug and create a misleading impression of the safety of the drug", wrote the FDA.
The FDA also notes that Lomaira is only indicated in the short term in patients with a body mass index of 30 kg / m2 or greater than or equal to 27 kg / m2, with other risk factors such as controlled hypertension , diabetes or hyperlipidemia.
In response, the FDA is asking Avanthi to stop labeling Lomaira and provide an action plan to broadcast "true, non-misleading and complete remedial messages" to the audiences who received the promotional material.
Wednesday, December 6, 2017
FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility
The United States Food and Drug Administration (FDA) UU has released a highly drafted form 483, sent last month to Glenmark Pharmaceuticals manufacturing facilities in Solan, India on Tuesday.
One of the seven observations on Form 483, first announced by the company on Nov. 28, noted that FDA inspectors found at least 13 quality documents "crushed into the teeth and internal moving parts of the crusher ". "
The FDA stated that the quality documents were not in the logbook as required by one of the site's standard operating procedures.
Further comments focused on the fact that the site did not thoroughly investigate unexplained lot spreads and failures, deficiencies in complaint files and lack of written procedures for production and process controls.
In one case, Form 483 indicates that the company attributed a batch error to the sample preparation error "by providing photographs of sample vials indicating alleged preparations of abnormal samples". The photographs included in the survey did not include stamps. of date ... The authenticity of the supporting photographs could not be verified by the investigators of the FDA. "
Glenmark stated that the manufacturing unit that received Form 483 contributes about 10% of the company's sales to the United States. UU And that the company "is in the process of providing a complete response to the observations."
One of the seven observations on Form 483, first announced by the company on Nov. 28, noted that FDA inspectors found at least 13 quality documents "crushed into the teeth and internal moving parts of the crusher ". "
The FDA stated that the quality documents were not in the logbook as required by one of the site's standard operating procedures.
Further comments focused on the fact that the site did not thoroughly investigate unexplained lot spreads and failures, deficiencies in complaint files and lack of written procedures for production and process controls.
In one case, Form 483 indicates that the company attributed a batch error to the sample preparation error "by providing photographs of sample vials indicating alleged preparations of abnormal samples". The photographs included in the survey did not include stamps. of date ... The authenticity of the supporting photographs could not be verified by the investigators of the FDA. "
Glenmark stated that the manufacturing unit that received Form 483 contributes about 10% of the company's sales to the United States. UU And that the company "is in the process of providing a complete response to the observations."
Subscribe to:
Posts (Atom)