Having attended several conferences where the topic of DSCSA has been discussed, and listening to leading vendors (those that provide both hardware and software) opining on how the industry is behind the eight ball in obtaining equipment and full integration, and validation due to long lead times with the number of vendors available, it appeared logical that a document on the availability of waivers might be in the cards.
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,
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 ANDAs approved was significant less.
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,
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 and seek expediated review.
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 attributes,
With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate. While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea. ABC News (here) seem to validate my opposition.
The FDA has struggled with the best methods to determine the bioequivalence of topical dermatological drug products for years. For example, FDA considered numerous methods including transepidermal water loss (TEWL), skin stripping, and others to demonstrate the bioequivalence of retinoid acne products. None were found acceptable and the Agency ultimately relied on bioequivalence studies with clinical endpoints to approved generic versions of these cream,
Here we are at April 11th and through the 9th, the first 6 business days of April, there have been 5 ANDA full approvals reported so far on the FDA’s Recent and New and Generic Approvals list (here as of the morning of April 11th at 730AM). April 2 and 3 saw no approvals reported and the 4th,
OGD just released its March 2018 ANDA Approvals and receipts data. The results are even stronger than reported earlier (here). March officially saw 56 full approvals and 11 tentative approvals, a few more than we saw on April 3rd, as the databases became fully populated over the next few days. None of the approvals or tentative approvals were reported as first cycle approvals in the March report.
Before we get to the guessing game, for those of you who are not familiar with the term, let’s define what an Authorized Generic (AG) is. Most commonly, an AG is a brand name drug that is marketed without the brand name. It may be marketed directly by the NDA holder or by a third party.
March approvals appear to be moving in the right direction as firms, apparently, are catching up with elemental impurity issues and their amendments are working their way through the review and approval process. Unofficial March ANDA approval numbers taken from the Recent New and Generic Drug Approvals list (here) show 50 full approvals and 10 tentative approvals.
It has been just about 11.5 years since FDA approved an OTC version of MiraLAX and the innovator withdrew the Rx-labeled NDA product from the market. Why did it take this long? Other than the fact that ANDAs approved prior to the approval of the OTC version were making significant profits, there were differences between how the ANDA applicants and the FDA viewed the change in labeling.