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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

Do Dietary Supplements Have a Target on Their Backs?

In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.”  The Agency noted that the ingredient has been the subject of numerous report of serious adverse drug events.

Annual Report on Postmarketing Requirements and Commitments Shows Continued Progress

Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications.  In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.

Proposed Rule Will Supplant FDA Informed Consent Guidance When Finalized

The FDA is proposing a rule, as announced in the Federal Register (FR) (here), to provide for relaxing the provisions of informed consent under specific circumstances.  The history of the change is explained in the FR notice.  The FDA notes that the Cures Act has provided it with the statutory basis to support the proposed regulation,

Official October OGD Numbers Are In, and Yes,  Another Record!

While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here)  on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2.  OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!

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Latest News

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.

Fran Zipp Elected Vice Chair of ISPE International Board of Directors

LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The newly elected Board includes LCS’ own CEO and President,