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Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world.
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Our blogs feature and report on the latest news and trends in the industry.
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Latest Blogs

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,

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 warnings. 

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Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).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 additional examples and clarifying language. 

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Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more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 (here). 

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Latest News

Compliance 360 – A podcast survival guide to US FDA enforcement and compliance

Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.

Compliance 360° is hosted by Medtech Insight

PODCAST LINEUP

November 28,

Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman Consultants

LCS’ CEO, Fran Zipp, was interviewed by Economic Times during a meeting of the ISPE India affiliate.

Click here for the full interview.