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In a notice on the CDER webpage today, FDA published 32 new draft bioequivalence recommendation documents and revised 19 previously published recommendations. The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”. The two DPI...

In another flurry of guidance issuances, FDA has provided (what I thought would be) a really good read. I was hoping that the long-awaited Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (here) would have some new insight into choosing which regulatory submission path to follow; however, while being a good...

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 goals dated 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 GDUFA I...

The FDA posted its final approvals and receipts numbers for FY 2017 today. We thought there might be a blip in receipts due to firms trying to beat the GDUFA II fee clock which took effect on October 1, 2017, and we were right. OGD received a whopping 202 ANDAs in September. This was not a record month in FY 2017, in December 2016 OGD received 235...

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 Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing. The...

Lachman Consultant Services

 •  September 22

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...

Lachman Consultant Services

 •  September 18

The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to...

Lachman Consultant Services

 •  September 4

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)...

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...

The generic drug user fees for year 1 of GDUFA II have been announced by FDA. There are 2 fundamental differences in the GDUFA II fee structure relative to GDUFA I. First, GDUFA I was built on the assumption of OGD receiving about 750 ANDAs per year. The average number of ANDAs received over the 5-year GDUFA I period was just over 1000 ANDAs. As a...