Compliance

14
Jun

Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic […]

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03
Jun

FDA Publishes Four Guidances on Supply Chain Security Issues

The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]

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27
May

Is This the Beginning of Withdrawal of the Withdrawal of the Unapproved Drug Initiative?

In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]

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30
Apr
Quality Agreements Image

Important ISPE Meeting on Quality Risk Management Sustainability

On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management.  Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]

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29
Apr

Day Two of the Generic Drug Forum – Morning Sessions

Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives.  Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]

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29
Apr

Day Two Generic Drug Forum Afternoon Sessions

The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms.  The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]

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23
Apr

Paper Inserts for Prescription Drugs – a Dinosaur That Won’t Go Away

An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry.  Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]

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15
Apr

Remote Inspection Guidance Now A Reality But Will It Solve the Backlog of Inspections?

Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]

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25
Jan

Compliance/Enforcement Activity, the Slow Down, and Predictions

Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry.  COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry.  High […]

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08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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