Generics

18
Dec

Get the Government into the Manufacture and Distribution of Generic Drugs – Who Thought This One Up?

It looks like Senator Elizabeth Warren thinks it is a good idea! (see here!)  I think it is poppycock!  Just think of the problems we have now with drug shortages and recalls.  The stringent nature of the cGMPs and pharmaceutical manufacturing, in my opinion, do not lend well to government intervention.  What a conflict of […]

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14
Dec

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month. Of […]

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13
Dec

FDA Publishes a Bonanza of Regulatory Documents on Biotech Products – a Deeper Dive

Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week.  These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft, a Q&A Guidance […]

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13
Dec

FDA Withdraws Proposed Labeling Rule – Finally!

After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs.  The advance publication notice in the Federal Register can be found (here).  The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or […]

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12
Dec

Revision to Data Integrity Guidance Issues

Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).  The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.” The guidance does have […]

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03
Dec

OGD Issues Guidance on Post-Complete Response Letter Meetings

The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings.  As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose […]

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28
Nov

22 New and 41 Revised BE Guidance Documents Posted!  AAM Continues to Voice Same Concerns

While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process.  It seems that we are not alone! In remarks made at the November 27th FDA […]

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28
Nov

Did Someone Forget User Fees?

I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S.,  Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting  Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November […]

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