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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 […]

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices. It was recognition that medical devices are different and that the review process had not been thoroughly re-examined in two decades. I imagined tweaks, possibly substantial ones, to the 510(k) process. I also predicted that those […]

In previous posts, FDA Matters has expressed its disdain for efforts to solve problems by reorganizing government agencies. So, it may be surprising that I am giving Commissioner Hamburg an “A” for her recent reorganization of FDA’s senior management. In the reorganization, she is addressing four crises that beset the agency: industry discontent with the […]

Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) recently had some alarming words of warning for medical device manufacturers operating in the United States. According to Dr. Shuren, a number of different factors have come together to place unprecedented pressure and strain on the medical device industry, with no clear indicators […]

Responses to FDA 483’s and Warning Letters are usually fully of commitments. They involve “what” will be done to correct compliance problems, and “when” it will be done. FDA has even started to ask “how” they will be done, meaning—Do you have the resources to do the work? If these questions are not fully addressed […]