Resources

This past spring, medical device companies – and all other organizations participating in clinical trials – became subject to a new Final Rule regarding informed consent. Specifically, the FDA implemented changes to existing informed consent regulations that now require the submission of clinical trial descriptions to the public ClinicalTrials.gov databank. Trial participants must be informed of […]

Smaller medical device companies aren’t imagining things – it really does take longer to receive 510(k) approval for medical device developers with fewer than 100 employees than it does for larger industry players.  This startling information comes from a study published this summer by researchers at Northwestern University, which took a hard look at how […]

Did you know that your career can be ruined, or you can even do jail time, in a product recall? It has happened. Read here. And here. All FDA and DOJ have to show is that you ‘should have known’ about problems with your product. “I didn’t know” is NOT a defense! That low standard […]

The cover of Fortune magazine popped off the newsstand shelf last month: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011) Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on […]

FDA has recently introduced a guidance document titled—“Oversight of Clinical Investigations: A Risk Based Approach to Monitoring.” FDA has not released a similar guidance for over twenty three years. The guidance is intended to assist sponsors of clinical investigations with clinical trials relating to human drugs, biologics, and medical devices. Although the overriding theme of […]

Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year. In 2010, the FDA issued 10,407 483s, breaking the previous high-water mark of 9,666 in 2009. Through June 30, 2011, the FDA has issued 5,547 […]

FDA Matters thinks biosimilars will be a huge success. FDA-approved products similar to off-patent biologics (“biosimilars”) will be available in the US by 2014 or 2015, with more added each year. There will eventually be price competition in the range of 20% to 40% discounts. Biosimilars will be used in most health care settings with […]

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products. Specifically, a number of device types will now be exempt from premarket notification requirements. The move, […]

The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. (See The QA Pharm, August 7, 2011.) Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly […]

The pharmaceutical Quality Unit has been the target of many FDA Warning Letters as the underlying cause of product quality and CGMP compliance problems. We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA […]