The Office of Generic Drugs (OGD) filled in the remaining data boxes in the March Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) and there are some very interesting numbers to point out. Of the 9 refuse-to-receive (RTR) actions OGD issued last month, 6 were for GDUFA II priority applications, 1 […]
The Chart below was posted late yesterday on the CDER webpage. The most notable figures are the mean and median approval times and the significant reductions over those of the first quarter of FY 2018. This appears to indicate that either approval times were much shorter in the second quarter or the number of old […]
By now we all know that the fee structure for NDAs and BLAs has changed with the passage of PDUFA VI. We know that now there are only application fees and “program fees” (program fees are the same as previously assessed product fees). The FDA issued a final guidance entitled “Assessing User Fees Under the […]
The climb back to what we have come to see as the new normal for approvals continued in April. The unofficial April approval numbers obtained through the daily approvals and FDA all approvals databases (here and here) lists 62 full approvals and 9 tentative approvals. This comes after a January low of 25 approvals, February’s […]
On April 16th we posted a story (here) on the FDA guidance document titled Highly Concentrated Caffeine in Dietary Supplements (here). That post detailed the FDA’s position on highly concentrated caffeine powder and liquid products sold to the consumer and the potential public health issues that they present. In that guidance, the FDA also discussed […]
While reading a commentary today in Investor’s Business Daily (here) written by Peter Pitts, a former FDA Associate Commissioner, I became confused. The article’s focus was on two pieces of legislation (Creating and Restoring Equal Access to Equivalent Samples [CREATES] Act and the House’s Fair Access for Safe and Timely [FAST] Generics Act) and Mr. […]
The Office of Pharmaceutical Quality (OPQ) today published a Manual of Policy and Procedures (MaPP) document titled Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (here) for new drug applications and biologic license application holder that submit a prior approval supplement […]
Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.” FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document. The Q&A document referenced above responds to those questions. […]
On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”. The original guidance was published November 13, 1998. The revision spans some 50 pages of discussion about critical quality […]
Almost everyone in the generics industry is familiar with the FDA Paragraph IV database (aka list). As described by the Agency, the list is published “[a]s part of its ongoing efforts to assist generic drug applicants in preparing their applications, FDA regularly publishes a list of drug products for which an ANDA has been received […]
