The Lachman Blog

06
Oct

New MaPP – Shuts Door on ANDA Review Status Requests from Other than Authorized Representative

The Office of Generic Drugs (OGD) has long taken the position that calls from multiple industry representatives about the same application to different OGD review staff or senior staff do nothing but waste the time of OGD.  This is definitely accurate; however, those multiple calls in the past were made because information was difficult (if […]

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04
Oct

Major and Minor Amendments Under GDUFA II – Read Me Loud and Clear

The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements.  The system for classifying the goal dates has been simplified from a tiered system under […]

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03
Oct

RTR a New Q&A Guidance!

OGD has released a new Q&A document relative to refuse-to-receive issues.  I must be quite frank, there were some questions and their answers of which I was not aware.  Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior […]

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03
Oct

Synthetic Peptide Products Eligible for ANDA Submission – Maybe!

After years of internal FDA debate, the FDA issued a guidance yesterday which was designed to assist an ANDA applicant in “determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted […]

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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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