RAC US Exam Question No 8

Question No 8:

 A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will form the primary basis of an efficacy claim in an NDA. Which of the
following is TRUE?

A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite FDA feedback
B. An SPA provides an opportunity to focus on general drug development issues
C. The SPA request will be handled as a request for a Type B meeting
D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same protocol

Answer: D

CDRH Unveils Top Regulatory Science Priorities for 2016

(FDA) Center for Food and Drug Administration for Devices and Radiological Health (CDRH) try to better exploit big data and advance the use of the results reported by patients in making regulatory decisions, according to a list 10 Regulatory scientific priorities on Tuesday.
The release of the list coincides with the primary objective of CDRH regulatory science, which is to help develop and implement tools, standards and methodologies to study the safety, efficiency, performance and quality of devices

Top 10

While serving as a way to help CDRH make strategic decisions on the funding of research to ensure that research in the division focuses on the challenges, gaps and regulatory requirements relevant to science and radiation-emitting products medical devices, The list includes:

•  Leverage "Big Data" for making regulatory decisions
•  Using evidence from clinical experience and the use of evidence synthesis
•  Improve the quality and efficiency of reprocessing reusable medical devices
•  development of computational modeling technologies to support regulatory decision making
•  Improve the performance of the digital health and medical device cyber security
•  integration of human factors engineering principles in the design of the device
•  Modernization and bio compatibility evaluation of bio hazard materials Devices
•  Promote methods to predict clinical performance materials and medical devices
•  Promote the use of outcome measures reported in patients taking regulatory decisions
•  Preparation and use of the experience and preferences of the patient regulatory decisions

Security

Security has always been a priority for CDRH, while the report notes that there is "a gap in the availability of tools and methodologies to assess the impact of different types of materials and the quality of materials, performance, and security devices doctors, especially when trying to predict long-term clinical results. "
Among other things, CDRH test new methodologies and tools that more accurately predict the clinical impact of surface coatings, corrosion of materials and additive manufacturing in the quality of equipment, performance and safety. In addition, CDRH promote the development of substitute materials and try to increase the safety of the design of the devices.
The center also requires more research to understand how to improve the performance and safety of medical devices, and understand the impact of software changes in device performance.

RAC US Exam Question No 7

Question No 7:

The Food and Drug Administration Modernization Act (FDAMA) established two types of formal early collaboration meetings. Which of the following is one of those
meetings?

A. PDP meeting
B. Agreement Meeting
C. Pre-IDE meeting
D. Type A meeting

Answer: B

Professors Call on Congress to Make More Info Public on Generic Manufacturers

While discussions on the reuse of generic changes Drug User Fee (GDUFA) will continue, both professors at MIT and the University of Chicago are asking Congress to require the Food and Drug Administration (FDA) to be more transparent about companies that manufacture generic drugs.
The call for greater clarity Rena Conti, assistant health policy at the University of Chicago professor, and Ernst Berndt, professor of Applied Economics at the Sloan School of Management at MIT, comes as both have argued during a hearing the FDA reauthorization GDUFA the number and identity of generic manufacturers, particularly in the way they use manufacturing organizations (CMO) contract ", is wrapped in the public control", which can be a problem for public health.
Specifically, teachers want FDA to disseminate information on the manufacture and site facilities each generic drug, reduce incentives for companies that use the new CMO and incentives to increase the number of generic companies to reduce the likelihood shortages or supply disruptions.
"Only when doctors know the identity of the drug manufacturers can reassure patients and their families as the provision of essential drugs is meeting high standards of quality," Conti Berndt and writing.

Breakdown of Recommendations

In the current version of GDUFA, FDA collects information about pharmaceutical active ingredients (API) and final drug filling and finishing (fdfs) production facilities in the collection of user fees, including the use and the identity of the sponsors (ANDA) CMO abbreviated new drug application.
"Without the imposition of the burden of additional response sponsors ANDA, FDA could provide a valuable service to the public with this information," say the teachers, adding that the FDA may also make public the information on which generic drugs are manufactured by OCM and the manufacturing sites, in particular the use of the CMO has more than doubled between 2001 and 2010.
"This database should be available in electronic format and can be searched by the drug, formulation, sponsor of ANDA, CMO, and location of production facilities," they say.
As for mitigation incentives for generic companies using OCM, teachers called on Congress to restructure user fees so that some facilities rates move to own fresh produce, which they claim could reduce dependence on the CMO and make the supply of certain generic drugs are less likely to be disturbed.
"From the annual user fee is the site rather than specific products generates incentives for the OCM to increase the number of products made on their website ... the increase in fixed costs and economies of scale induced GDUFA You can lead the continued outsourcing OCM manufacturing and reduce the number of generic specialty manufacturing and non-specialized drugs, increasing the concentration of production and make the supply chain more vulnerable drug supply disruptions organizations separate, "the teachers say.
The teacher recommendations also come as an increasing number of generic drugs and active pharmaceutical ingredients (API) manufacturers in recent years, particularly in India, they should be notified by the FDA, or they have said stop sending drugs or generic API in the United States, which weighed about generic supplies.

Negotiations

Concerns In June, the Generic Pharmaceutical Association (GPhA), upper lobby of the generic industry, and the Society of Chemical Manufacturers and Affiliates Products (SOCMA) has also raised about how fees GDUFA place burdens for smaller generic companies size.
Unlike Agreement rates for medical devices (MDUFA) GDUFA not include provisions guaranteeing reduced for small manufacturers and journalists for the first time types.
Industry groups have met with the FDA last June in an attempt to negotiate a new version of GDUFA before his authorization expires on September 30, 2017. The comment period for the public meeting GDUFA record, which includes 21 comments industry and others, was open from 21 April to 15 July 2015.

RAC US Exam Question No 6

Question No 6:

A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all products have been either parts for Class II medical devices or Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should as in order to begin assessing the impact of Class III on plant operpations?

A. Is it a sterile device?
B. Is it a component or device that would be manufactured?
C. Is it an implantable device?
D. Is it a single use device?

Answer: B

Leaked TPP Chapter on IP Sets Terms of Biologics Data Exclusivity

Information about exclusivity provisions biological data on the Trans-Pacific Partnership is still cloudy despite trailing copy the final chapter of TPP in WikiLeaks intellectual property rights Fridays.

The section of the chapter on the exclusivity of biological data seems to offer two options regarding the "first marketing authorization" of a new organic product. Affected countries should provide "effective protection market .. for a period of at least 8 years from the date of first marketing authorization "or" for a period of at least five years from the date of the first marketing authorization.

However, for the period of five years, the text seems to leave the door open to other provisions that could extend this period, with the ambiguous statement "other measures", which is just above the claim that countries recognize "that market conditions also contribute to the effective protection of the markets. "

The chapter also adds applicants organic businesses "may apply for approval of a pharmaceutical product is a biological product ... within five years after the entry into force of this Agreement, provided that other pharmaceutical products in the same class have been approved by the Party. "

In addition, a number of governments of the PPT, including Australia and New Zealand, said many do not require them to spend five years of exclusivity.

Some countries have transition periods, and the text shows also beyond these periods would last from three to ten years.The much says PPT Committee will consider the exclusivity period after 10 years.The TPP negotiating countries include the US, Mexico , Canada, Japan, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand and Brunei. The US Congress has 90 days to approve the final terms of the agreement, to be officially released in November.

RAC US Exam Question No 5

Question No 5:

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital for reversible medical consequences as a result of the defective product. What type of recall classification would be assigned to this product.

A. Class I
B. Class II
C. Class III
D. Class IV

Answer: B

FDA Warning Letter Calls Out Device Distributor

When a device is officially a medical device? And when a distributor is officially a manufacturer? Last warning letter (FDA) of the US Food and Drug Administration for MedSource based in Rhode Island may raise some new issues of companies that do not realize that they must comply with FDA regulations.

For MedSource, the FDA has determined that the distribution of orthopedic surgical instruments trays means that a device manufacturer and distributor because the products "are intended to be used in the diagnosis of disease or other conditions or" in cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body.

On its website, MedSource describes himself as only a distributor of orthopedic products from other manufacturers, equipment for sports medicine and physical therapy products.

Findings

MedSource Inspection Agency device operations in March found that the company failed to adequately control its warehouses and dormitories share purchase in order to avoid "confusion, damage, deterioration, contamination or other adverse effects to await his use or distribution. "

Inspectors also found that orthopedic trays awaiting delivery to customers have been stored immediately adjacent to an area where employees already inspected trays used in surgery. In addition, the FDA has found an immediate container of fuel near other orthopedic trays and trays of instruments.

The failure to establish acceptance activities MedSource, even returned to the factory for distribution units, was also cited by the FDA, as has been its inability to establish and maintain procedures for verification and validation of corrective and preventive actions.

Other issues on quality systems the company have been raised.

The agency also said MedSource he must be aware that one of the products it distributes - Optecure CCC + (allograft demineralized bone matrix + CCC) - is a medical device because when demineralized bone matrix combined with bone filler material, monitoring the product is considered a medical device, which means "the methods used or the facilities or controls used in the production, packaging, storage or installation must be in accordance with good manufacturing practices (cGMP) requirements for current devices."

RAC US Exam Question No 4

Question No 4:

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976. t can use one of the following regulatory paths:

A. IDE
B. PMA
C. 510(k)
D. Special Assessment Protocol

Answer: C