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505(q) Petitions Still Eating Up Valuable Agency Resources

The FDA has released its required annual report on 505(q) petitions.  Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act.  Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has outlined the history of 505(q) petitions and the issues addressed in the report here:
He did such a good job that we are not going to delve further into the numbers. 

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Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Issued by the FDA

This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission.

The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application.  

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From Global Leader to Global Authority!

 

The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals.  While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals. 

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Got Life? – Check Out the Analytical Procedure Lifecycle

During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.

There are three lifecycle phases:

  • Procedure Design and Development
  • Procedure Performance Qualification
  • Continuous Procedure Performance Verification

A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).  

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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,

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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.  

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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”.  

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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,