Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated. Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day. They say history repeats itself – no I am […]
After a disastrous start to the new year and the significant slowdown in approvals resulting from the OGD’s strict application of the provisions of the USP Elemental Impurity Chapter while awaiting harmonization with ICH Q3D, the approvals have begun flowing again. There are some changes in the final guidance (here) from the draft that the […]
On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”. This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller […]
Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more. Since February 2018, the FDA has issued sixty-one new guidances and revised forty. The OGD has indeed been busy but while the industry loves to see the new guidances, […]
In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers […]
Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance. The FDA announcement states: The U.S. Food and Drug Administration is alerting health care professionals and patients of a […]
“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.” 21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption […]
Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here), which attempts to develop […]
Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages. Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary […]
Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines. Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part […]
