The Lachman Blog

26
Sep

Martin Shimer Reviews Patents and Exclusivity

In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with. Patents are pretty straight forward, with the […]

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25
Sep

Ricki Chase, M.S., Director, Lachman Consultants, to Present at American Pharma Outsourcing Summit

Ricki Chase, Director, Compliance Practice, will be presenting at the American Pharma Outsourcing Summit taking place September 27th and 28th, 2017 at the Doubletree by Hilton Boston North Shore. Ricki will be presenting on the Regulatory Hazards of Outsourcing, and will cover the following areas: Approving products on a batch-by-batch basis Establishing laboratory controls Training […]

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21
Sep

Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities […]

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20
Sep

FDA Announces Outsourcing Compounders Fees

The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018. Compounders Outsourcing Fees FY 2018 Establishment Small Business* $5,364 Non-Small Business $17,364 Re-inspection Fee $16,093 * To qualify revenue must be less than $1,000,000 for all sites and affiliates The Notice states that “FY 2018 registration period for […]

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15
Sep

UGA’s Wided Najahi-Missaoui Granted First Women in Pharma Scholarship (iSpeak blog, ISPE, September 8, 2017)

Wided Najahi-Missaoui, MS, PharmD, doesn’t know the meaning of the word “can’t.” Since arriving in the United States from Tunisia in 2000, she has earned two graduate degrees (a close friend says she collects degrees like others collect stamps), and accolades. Her mentor, Dr. Michael Griffith Bartlett, who is Professor and Director–BS Program at the […]

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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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