Last month FDA published its 4th annual report on the state of pharmaceutical quality and, needless to say, there were some interesting statistics, particularly for us FDA nerds. Number of Manufacturing Sites and Registered Products The report states that for fiscal year 2021, there were 4,451 CDER …
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 …
On August 7th, FDA Commissioner Dr. Stephen Hahn, CBER Center Director Dr. Peter Marks, and FDA Deputy Commissioner Dr. Anand Shah published an article in the Journal of the American Medical Association (JAMA) outlining what the review standards would be for the COVID-19 vaccines currently …
On July 10th, FDA announced its goal of restarting domestic on-site inspections beginning the week of July 20th. The regions of the U.S. that will be on the receiving end of these inspections are those that the agency’s rating system demonstrates are the safest for …
It has been over three months since FDA issued its press releases stating that it was postponing most foreign and domestic facility surveillance inspections (see here and here). Since then, apparently only “mission critical” surveillance inspections have taken place, leaving the bulk of registered facilities …
In a press release issued on April 3rd, FDA reiterated its warning to stem cell clinics (and implicitly to other HCT/P facilities that are benefiting from enforcement discretion), asserting that the agency has stepped up oversight over such facilities, and will be ramping up even …
After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made …
As difficult as it might be to believe, its true. In fact, last week, the FDA Commissioner, Dr. Scott Gottlieb, and the CBER Center Director, Dr. Peter Marks, issued a press release cautioning consumers against receiving “young donor plasma infusions” that are promoted as unproven …
Enforcement discretion for stem cell facilities (and certain other HCT/P manufacturers) ends in November of 2020, and as FDA indicated in a recent press release, the agency is “discouraged” by the dearth of manufacturers wanting to interact with them during the enforcement discretion period. Back in …
In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such …
FDA issued its final Guidance on Data Integrity on December 12. The federal government has sworn off regulating by guidance (see blogpost here about Brand memo). In fact, at the Food and Drug Law Institute (FDLI) Enforcement and Litigation Conference that was occurring simultaneously with …
CDER recently published a new Manual of Policies and Procedures (MAPP 5014.1) for the site selection model used by CDER staff to prioritize manufacturing sites for routine cGMP inspections. The goal of the changes associated with the MAPP is to promote the effective and efficient …
Earlier this month, FDA published a Notice of Availability for its Draft Guidance entitled, Field Alert Report Submission, Questions and Answers. We have previously blogged about Field Alert Reporting (FAR) requirements here and here. The draft guidance makes recommendations to NDA and ANDA holders regarding the …
In 2016, FDA published the Q7 cGMP Guidance for Active Pharmaceutical Ingredients. It outlines best practices for everything from quality management issues, personnel, buildings and facilities, equipment and recordkeeping, to validation, change control, complaints and recalls. While it provides very useful information to stakeholders, in …
On January 22, 2013, FDA published its final rule on cGMP requirements for combination products under 21 CFR Part 4. Specifically Part 4.4 provides two mechanisms for combination product manufacturers to comply with the cGMP requirements: either by complying with all the cGMP requirements of …
