This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the …
A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection. We haven’t seen an FDA Warning Letter citing a refusal to permit photographs for years, so, just as FDA is apparently reviving …
Primacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Maybe that’s also why FDA last week publicized the highest number of …
We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April …
A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Many …
Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug …
At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office …
Please sing to the tune of “Honesty,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs …
The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the …
A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. …
Sentencing for defendants convicted in federal court of felony offenses that involve fraud, including violations of the Federal Food, Drug, and Cosmetic Act, may be dramatically reduced based on an opinion issued last week by a panel of the Third Circuit Court of Appeals. The …
Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the …
Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials …
Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”). Unless amended, the proposed legislation …
On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. Circuit, FDA published a Federal Register Notice today (August 9) soliciting comments …
