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. 

ICH Q7 cGMPs for APIs Q&A Guidance Issues

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. 

Got Some Time on Your Hands – New Quality Guidance for MDIs and DPIs Issues

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,

Paragraph IV Certifications Last 4 Plus Years

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 by the Office of Generic Drugs (OGD) containing a Paragraph IV patent certification.

So How is that Prescription Drug Imported On-line from Canada?

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.