05
Nov
Keeping an Eye on The Ultimate Goal Image

Keeping an Eye on The Ultimate Goal – How to Ensure Success In Developing Complex Generics

One of the popular sessions in GRx+Biosims Conference held in Bethesda on November 4, 2019 was about Developing Complex Generic Products – How to Ensure Success. The session involved presentation and discussion by FDA and industry. Both sides agreed that the most important factor in assuring success in the development of complex generic is communication, […]

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04
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

AAM GRx-Biosims Meeting Day One Morning Highlights

The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were: Record breaking […]

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01
Nov

First Month of FY 2020, October Approval Numbers Look Like Tail of 2019

I am pleased to report that the approval and tentative approval actions are again appearing on the daily approvals and All Approvals listing on the FDA website again.  So far, it looks like another of the slower months for approval and tentative approval actions to start off the new fiscal year.  To date (through October […]

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31
Oct
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Image

Revision to the Guidance “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”

Today, the FDA issued Revision 1 to the above-referenced guidance.  According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’  This draft guidance addresses changes […]

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30
Oct
Drug Shortages Report Provides Look Forward Image

Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created […]

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28
Oct
Notice of Opportunity for Hearing Proposal to Withdraw Two ANDAs Implicates Cetero BE studies Image

Notice of Opportunity for Hearing Proposal to Withdraw Two ANDAs Implicates Cetero BE studies

In two separate Federal Register (FR) Notices on the FR prepublication page (here and here), the FDA proposed to withdraw approval of two ANDAs based on lack of confidence in the bioequivalence data contained in the applications.  The concern relates to a problem at a bioequivalence testing laboratory.  The Notices state: “In May 2010 and […]

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25
Oct

Homeopathic Drugs Moving Closer to the Front Burner

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017. The document […]

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23
Oct

Have Postmarketing Study Requirements? You May Want to Read This!

FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.  If you have any post approval study requirements for any of your products, you should pay close attention to this document. In describing the document, the Agency says: “This […]

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22
Oct
Document Issued for Manufacturing Facility Information Image

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc. The document provides specific guidance on what, where, and how to list such […]

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