The Latest News Coming From the FDA and the Institutional Review Board

Ethics/Regulatory

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FDA completes recommendations for three user fee programs

Wednesday, January 18, 2012 12:18 PM

The FDA completed its recommendations Jan. 17 for three user fee programs to help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.

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FDA holds J&J under magnifying glass

Friday, January 13, 2012 01:34 PM

The FDA has trained a watchful eye on Johnson & Johnson as delayed reports, recalls and court trials pile up.

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FDA says Opioids may be found in Novartis OTC drugs

Wednesday, January 11, 2012 11:25 AM

The FDA has released an advisory regarding the Novartis recall due to the mixed bottling of products. While previous reports suggested that the OTC drugs NoDoz, Excedrin, Bufferin and Gas-X had simply been mixed with each other, the FDA now is warning patients that high-powered, prescription-only opioid drugs may have found their way into Novartis OTC packaging.

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Novartis recalls OTC drugs, temporarily closes U.S. plant

Monday, January 9, 2012 01:51 PM

Novartis is recalling several over-the-counter products such as Gas-X, Excedrin, NoDoz, and Bufferin due to inconsistent bottling, as well as broken gel caps and chipped pills.

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Johnson & Johnson halts Doribax trial due to ‘significant safety concerns’

Monday, January 9, 2012 09:20 AM

Johnson & Johnson shut down a clinical trial of antibiotic Doribax after causing excess mortality and a numerically poorer cure rate than pneumonia subjects treated with imipenem-cilastatin, the generic version of Merck’s Primaxin.

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Delcath's Ireland location achieves ISO 13485 Certification

Wednesday, December 28, 2011 10:26 AM

Delcath Systems has reported that the company's Galway, Ireland location has achieved ISO 13485:2003 Certification--an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU's Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSATR Delivery System following its European CE Mark approval in April 2011.

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FDA, ABIA collaborate on safety and performance of materials in medical devices

Thursday, December 22, 2011 11:05 AM

Austen BioInnovation Institute in Akron (ABIA) and the FDA have entered into a collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.

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FDA proposes draft guidelines to address underrepresentation of women in clinical studies

Monday, December 19, 2011 12:11 PM

Draft guidance aimed to address the historic underrepresentation of women in clinical studies has been issued by the FDA. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

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PhRMA issues statement on biosimilar user fees

Thursday, December 8, 2011 10:20 AM

Pharmaceutical Research and Manufacturers of America (PhRMA) vice president Sascha Haverfield-Gross has issued the following statement about user fees for biosimilars:

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Schulman Associates IRB acquires Independent IRB

Monday, December 5, 2011 11:18 AM

Schulman Associates Institutional Review Board has acquired Independent
Investigational Review Board. The transaction allows both organizations, which protect the rights of human research subjects, to provide a more comprehensive suite of review services for pharmaceutical, medical device, contract research organization and clinical research site customers.

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