March 2019

28
Mar

Dietary Supplements – Using Contract Manufacturers

  As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer.  In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge.  Most dietary supplement marketers have demonstrated adequate control over their […]

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27
Mar
Young man looks at road map near on mountain road, Switzerland

Pediatric Labeling Information Road Map Provides Good Directions

This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive. The guidance goes on to […]

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26
Mar
Young woman with a flat tire

ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  And although […]

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24
Mar

Lachman Consultants Returns to ISPE Europe 2019

(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4, where they […]

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21
Mar

Amy Schutte, new Senior Associate, Regulatory at Lachman Consultant Services, Inc.

We are pleased to announce that Amy Schutte has accepted the position of Senior Associate, Regulatory at Lachman Consultants, effective March 28, 2019. She will report to Aloka Srinivasan. Ms. Schutte is a pharmaceutical industry professional with specialization in Regulatory Affairs and experience in quality, regulatory compliance, and pharmacovigilance. After nearly 20 years in the […]

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19
Mar

Particulate Material Back in the News

Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product.  One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).  This is reminiscent […]

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