Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.” This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized. For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,
A long time ago, I was an expert witness in a pay-for-delay (reverse payment) case where, to me, the facts were clear. The patent settlement meant that the generic product would be assured entry into the market 5 years before the patent expired (can you guess what case that was?). In that case, I thought it was a no-brainer,
The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age. FDA also warns this is not just a problem with younger age groups. The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly after use and can lead to serious and life-threatening consequences
FDA is asking all manufacturers to review labeling to include warnings about the event as they continue to monitor the situation,
The FDA has revised and finalized its previously issued (2011) Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry. FDA notes that “this guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective.” The Agency also indicates that several rulemaking activities will also be initiated that will address these products.
Since the 1938 United States Food, Drug and Cosmetics Act was put in place, legal requirements have existed mandating the integrity of the manufacturing and laboratory data supporting product quality and ensuring patient safety. However, only within the last 10 years has the topic of data integrity been widely discussed and numerous guidance documents (draft and final) have been published.
Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval. The FDA has taken this extraordinary approach to provide greater transparency regarding this issue.
Since its appearance in August 2007, the Guidance for Industry, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients has stood the test of time in providing clear and practical guidance to the pharmaceutical industry, as described in the guidance’s original objective, “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality”.
OGD topped the initial projection of both approvals and tentative approvals from my May 2 post (here) hitting 66 full approvals (predicted 62), and 16 tentative approvals (at the time there were only 9) for a total of 82 approval actions. This is good news for the generic industry, as it appears that each month OGD is moving back to its “new normal”.
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.
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 Prescription Drug User Fee Amendments of 2017” today which explains the fundamental issues associated with the new fee structure such as
- how fees are to be assessed
- when fees are assessed and due
- what waiver provisions are still in place and which are no longer available
- definitions of prescriptions drug products
- effect of failure to pay fees
- payment information and procedures
- fee waiver provisions,
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.