Resources

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 […]

The question of FDA regulation of medical device applications, also known as “apps”, intended for use on mobile devices such as smart phones and tablets is an open-ended one that MDCI has tackled in previous blog posts. A new frontier for medical device apps appears to have opened up, with the announcement by Ford that […]

The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011. The Big Stories of the Quarter The Drug Shortage:  Some people say the FDA is […]

The answer depends on who you listen to: the FDA or the EVP at CSL Biotherapies. According to the FDA Warning Letter issued on June 15, 2011, the issues are among the most significant as any we have seen in recent years following the company withdrawal of the vaccine after reports of seizures with use in […]

Years ago, while helping an incoming administration evaluate the public health service agencies at HHS, I became captivated by the idea that a series of reorganizations would solve many of the problems. I eventually snapped out of my trance and learned a life-long lesson: redrawing organizational boxes and altering reporting relationships are rarely effective solutions. […]