The Lachman Blog

13
Sep

PDUFA VI Fee Structure and Fees Announced – Gulp!

In a Federal Register (FR) notice published today (here), the FDA announced that the base amount for the prescription drug user fee (PDUFA) program for new drugs would be $878,590,000, plus another $22,415,658 from something called the “capacity planning adjustment”, which is based on the elements the Agency is using to calculate costs (see list […]

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04
Sep

OGD Delivers on First of Two Documents – Early!

Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here. The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types […]

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01
Sep

David G. Lonza, B.S. Engineering, new Head of EU at Lachman Consultant Services, Inc.

We are pleased to announce that David Lonza has accepted the position of Head of EU at Lachman Consultants, effective September 1, 2017. David Lonza joined Lachman Consultants in August 2016, in the role of Deputy Advisor to the President / CEO – Strategic Initiatives. David’s expertise includes servicing pharmaceutical / biopharmaceutical / biotech clients […]

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31
Aug

FDA Ducks Question of the Running of 3-Year Exclusivity In Digoxin Petition Response

On August 30, 2017, the FDA responded to three older petitions all submitted by the same law firm relative to Digoxin products.  See FDA’s full response here.  The petitions addressed three basic issues: 1) 3-year Hatch-Waxman exclusivity; 2) bioequivalence requirements for this narrow therapeutic index drug; and 3) dissolution and blend uniformity requirements.  The petitions […]

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29
Aug

FDANEWS Webinar: Combination Products: Managing Design Controls

Featured Speaker Ricki Chase, Director, Lachman Consultant Services Inc. Ms. Chase is former Director of the FDA Investigations Branch, where she was responsible for all operations including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase is an expert in implementation of food and drug law, compliance law, and current […]

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22
Aug

How Robust are Your Data Review Procedures?

The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review. Data review […]

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