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

RAC US Exam Question No 31

Question No 31:

Which of the following is considered part of the Device Mater Record?

A. Employee training record
B. Serial number label
C. Design reviews
D. Calibration records

Answer: B

FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika

The Food and Drug Administration (FDA) said Wednesday it will allow the use of an experimental blood test to screen donated blood for Zika.

In a statement, the agency said it allows the test developed by Roche Diagnostics for use in the blood of the screen in areas such as Puerto Rico, where the virus is transmitted actively.

When contacted for comment, a spokesman for Roche said Bob Purcell developed the screening test will begin with the "in the coming days."

Purcell also accredited by the FDA to help accelerate the availability of the test, saying. "The FDA was highly collaborative and responsive during the review of the [new application for experimental drug] IND Specifically, the FDA Center for Biologics evaluation and Research [CBER] was very quick and very clear with comments on the technical requirements and analytical scientists for verification and validation with clinical samples. "

The selection of blood donors

The authorization of diagnosis occurs after the FDA issued guidelines in February saying that blood and its components shall not come from areas Zika active transmission unless a screening test for blood donors FDA approved is available. However, the administration also notes that a "test of experimental donor under an investigational new drug (IND) ... may be permitted in situations approved technologies are not available."

blood donor FDA guidance also established a four-week postponement of blood donors diagnosed with Zika, or who meet certain risk factors, such as traveling to an affected or Zika had sex with someone area it has been diagnosed with the virus.

In particular, the FDA has not approved the Roche test for the diagnosis of the patient, and has licensed the test for screening blood donors under the IND. According to Purcell, "all new sites wishing to Zika tests for screening blood donations must be approved by the FDA before they can start [testing].

So far, the FDA has issued emergency use authorizations for two tests developed by the Centers for Disease Control and Prevention to diagnose patients Zika

Following the recommendations of the FDA, Puerto Rico stopped the local blood collection, and the Department of Health and Human Services (HHS) has started to provide the territory with the blood supply in early March.

However, the FDA said that blood banks in Puerto Rico will start collecting donations once the experimental test is available.

Roche also said its next step will be to prepare the deployment of proof in the southern areas of the United States is likely to see local transmission in the near future.

Research evidence

"The availability of an experimental test to screen donated blood for the virus Zika is, especially for those who already know the US territories active role in maintaining the safety of the blood supply of the nation step transmission "director Peter brands CBER said.

Works with Roche Cobas 6800/8800 test systems to detect Zika RNA plasma of blood donors.

"The cobas Zika has been specially designed using the generic Utility omni channel Cobas in the cobas 6800/8800 Systems. These systems provide high volume fully automated solutions for blood services for the virus and ensure that potentially infected blood units not are available for transfusion, "Roland Diggelmann, COO of Roche Diagnostics, said.