Is the FDA Telling You Something?  Final Bioanalytical Guidance May Point the Way!

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  This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.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that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,

FDA Warns of Potential Fatal Adverse Events with the Use of Benzocaine

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,

Let the Sun Shine on OTC Sun Screen Products

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.

MHRA, March 2018 ‘GXP’ Data Integrity Guidance and Definitions

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.  

Will Public Shaming Stop the Gaming of the System?

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.  

Q & A cGMP for APIs – a Deeper Dive

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”.  

With Implementation of Requirements Under the Drug Supply Chain Security Act (DSCSA) Rapidly Approaching, FDA issues Guidance on Waivers

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.

OGD Updates March 2018 Statistics

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,

PDUFA VI Fee Process Explained in Final Guidance

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,

MaPP 5310.3 on Expedited Review of PAS Supplements for NDAs and BLAs Tracks the Generic Process

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.