RAC US Exam Question No 35

Question No 35:

How many days does FDA have to review an Abbreviated 510(k)?

A. 30 days
B. 60 days
C. 90 day
D. 180 days

Answer: C

RAC US Exam Question No 34

Question No 34:

A new device undergoes design review. The review determines that current analytical data do not provide enough information to move ahead with human testing. A decision is made to discard the data and being a new study with the same protocol. This is an acceptable approach if:

A. The intended use of the product does not change
B. The original data are destroyed before new testing starts
C. the original data are stored in the device deign history file
D. The new study tests three times as many samples as the ole one.

Answer: C

Public Citizen Sues FDA Over Redacted Advisory Committee Info

The consumer group Public Citizen defense continues the Food and Drug Administration (FDA) in federal court in the practice of the agency that the information is correct in the curriculum vitae (CV) of the members of the Advisory Committee.

Public Citizen claims that the editors of withholding information about these external experts who could reveal the potential bias and provide relevant background in their professional qualification, according to a lawsuit filed in the US District Court for the District of Columbia on Wednesday.

The complaint:

In its complaint, Public Citizen calls the practice of the FDA to write the CV "arbitrary and capricious" and said that the body does not disclose proactively documents under the Freedom of Information Act (FOIA).

Specifically, the group believes that the reasoning of the FDA to draft a request does not meet the criteria of one of the nine exemptions of the FOIA that information is correct.

According to Public Citizen, about 90% of the CV on the website of the FDA for the members of the Advisory Committee contains essays (Center for Drug Evaluation and Research Drug, 92%; Center for Drug Evaluation and Biologics Research, 86 %, Center for devices and radiological health, 98%).

Public Citizen said first raised the issue of the FDA in a letter dated February 4, 2014 Public Citizen, said Sarah Kotler, who was deputy director of the FDA for Freedom of the Information Division, responded by saying the FDA policy is " categorically clean up "some information in the CV of members of advisory committees.

Editorial Advisory Committee:

FDA maintains about 50 advisory committees composed of experts from outside the weighing on scientific and medical issues specific agency. The agency generally meets Advisory Committee meeting when he wants to enter a new drug or device, or when looking at a specific safety issue for an approved product.

Although the FDA publishes the CV of members of advisory committees on its website, often writes information, such as "new degrees of dates, names of colleagues and mentors, the amount of subsidies received from private companies, and the names of the presentations and unpublished articles. "

According to Dr. Michael carome, director of Group Health Research Public Citizen, part of the Advisory Committee of the FDA pharmacy body composition he wrote his CV despite his request to be made available without redaction.

"The agency awards and written my military service and the amount of a grant from the National Kidney Foundation of long liquidation," he said. "The idea that the disclosure of this information would be an invasion of privacy or that it was confidential would be difficult to understand anyway - but after I had expressly indicated that the CV can be seen in its entirety, is ridiculous."

RAC US Exam Question No 33

Question No 33:

When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA. What is the most practicable first option for a company at this stage?

A. File a PMA immediately
B. Petition CDRH to down-classify the device (de novo process)
C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate
D. Submit this product for approval in Europe

Answer: C

Doctors Without Borders: Asian Trade Deal Could Restrict

Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics:

The (RCEP) comprehensive trade agreement regional economic association launches a new series of talks on Sunday in Australia and Medecins Sans Frontieres (MSF) suggests the rights of stricter intellectual property that could restrict access to affordable generic medicines for many Indonesia, Thailand, Myanmar, Cambodia and Laos.

Economic Regional (RCEP) Association is a free trade agreement (FTA) between the ten member countries of the Association of Southeast Asian Nations (ASEAN), which includes Brunei, Burma (Myanmar), Cambodia, Indonesia, Laos, Malaysia , Philippines, Singapore, Thailand, Vietnam, and the six states with which ASEAN has signed free trade agreements in place, including Australia, China, India, Japan, South Korea and New Zealand.

A chapter fled the negotiations, published this week by the International NGO KEI shows that Japan and South Korea have made proposals that go beyond what the rules of international trade and therefore require undermine access to medicines affordable generic.

Part of the chapter fugue states: "Each Party shall prevent applicants for marketing authorizations for pharmaceutical products which utilize new chemical entities that rely on or refer to the tests or other data submitted to the competent authority by the first applicant for a certain period of time from the date of approval of this application. from the date of entry into force of this Agreement, it is expected that this period will not be less than five years by the applicable laws of each Party ".

Two thirds of all acquisitions SPS drugs to treat HIV, tuberculosis and malaria are Generics India and reduce access to medicines, especially under the pretext of data exclusivity could block the entry of generic drugs to other regional markets, even for drugs that are already protected by a patent, the group said.

 "If the agreement measures prevent people to get generic drugs they need, the health consequences of any delay or interruption of treatment for many diseases, such as HIV, could be severe," said Dr. Greg Elder, MSF medical coordinator of Campaign access. "97% of HIV drugs MSF uses to treat 230,000 people living with the disease are generics from India. The reality is, not generic, would not be able to treat as many people as us. We urge the negotiators India and the Association to ensure that the terms of any trade agreement does not preclude the supply of generic medicines to us and many people in developing countries depend. "

MSF and KEI does not agree with the exclusivity provisions of the biological data of the Trans-Pacific Partnership negotiated last year.

James Love, director of KEI said. "The RCEP will be a massive trade agreement and the content of the IP chapter is important to join India and China, two countries excluded from the TPP ... Some of the issues that negotiators not included in the TPP, like the damages provisions are also lurking in the text, creating a risk that negotiators will be worse than you think, because the secret negotiations isolated negotiators timely feedback on complex technical issues. Japan and Korea are pushing to put monopolies test data without the same guarantees to patent monopolies ".

RAC US Exam Question No 32

Question No 32:

A medical device company allows its sales force to maintain a product inventory in the field. The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall?

A. Not a recall-it is considered normal stock rotation
B. Class I recall
C. Class II recall
D. Class III recall

Answer: A

FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

Three other Chinese pharmaceutical companies have added two Food and Drug Administration (FDA) lists import alert this week for failing to comply with good manufacturing practice (GMP) standards FDA to reject the FDA inspection.

On Wednesday, the FDA added Xinxiang and Xinxiang Pharmaceutical Co. Tuoxin Biochemical Co., stating: "Only pharmaceuticals and medicines (ie, adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are subject to DWPE [Detention Without physical examination] under this notice ".

The two companies have received FDA Form 483s in 2015, as Guangzhou Haishi Biotechnology Co., which has also been added to the alert list cGMP 14 March 2016.

Currently there are 44 Chinese companies on the list, which means that the products of these companies are prohibited from entering the United States. Between FY 2009 and FY 2015, the FDA conducted 1,389 inspections in China, but only 468 of which were conducted by the FDA Center for Drug Evaluation and Research Drug, and of those 468, only 23 inspection reports have called on companies to take formal action, according to the FDA panel data control.

Since 2014, the FDA issued warning letters to eight API and Chinese pharmaceutical companies, including: - More: http://www.raps.org/Regulatory-Focus/News/2016/04/08/24728/FDA-Continues-Crackdown-on-Noncompliant-Chinese-Pharmaceutical-Manufacturers/#sthash.x62qw5GP.dpuf

• Beijing Shunxin Co. Meihua Bio-technology
• China Resources Sanjiu Medical and Pharmaceutical Co
• Novacyl Wuxi Pharmaceutical Co. Ltd.
• Zhejiang Jiuzhou Pharmaceutical Co.
• Tianjin Zhongan Pharmaceutical Co., Ltd.
• Yunnan Hande Bio-Tech. Co. Ltd.
• Wuxi Kaili Pharmaceuticals Co., Ltd.
• Zhejiang Hisun Pharmaceutical Co.

The list of import alert and the number of inspections and warning letters grow as members of Congress recently criticized the handling of the FDA investigation of contaminated heparin from China that killed more than 100 in the United States 2007 and 2008, and back into the spotlight as the other French regulators discovered with the manufacture and supply of heparin in December inspection in china problems.

The Refusal of Inspection

In addition to the GMP concerns Yuneng based Ji'an Jiangxi Pharmaceutical Co. declined an FDA inspection of its facilities and pharmaceutical manufacturing was placed on alert for import.

"The refusal to allow inspection of a foreign operation, or provide reasonable access to staff FDA inspection, combined with other evidence, provides an aspect that the company's products are manufactured, processed or packaged in unsanitary conditions, "says the FDA.

Jiangxi joins other four Chinese pharmaceutical companies in the list of the FDA. According to the website of Jiangxi, the company manufactures dexamethasone sodium phosphate, betamethasone, deflazacort and steroids.

The new import restrictions come as China is struggling with the discovery that millions of vaccine doses used were improperly stored or outdated and