December 2018

20
Dec

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

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18
Dec

Ricki Chase Publishes Article in MedTech Insight

Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance […]

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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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11
Dec

Q&A Document on the Transition of Certain Protein Products Approved Under Section 505 of the Act to Deemed Approved Licensed Product

Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions.  FDA just issued a second revision of the question and answers document […]

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10
Dec

FDA Revises 503B cGMP Guidance for Outsourcing Compounders

On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here).  The initial draft guidance issued in 2014. According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s […]

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