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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...

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...

Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA advice about...

The FDA today, in the Federal Register, announced a public workshop to be held on September 12, 2017 to discuss the use of real world data (RWD) and real world evidence (RWE) in its regulatory decision making process. The workshop, titled, “Developing a Framework for Regulatory Use of Real-World Evidence”, will be held in Washington DC. It is...

Today, OGD released an updated version of a Q&A document entitled, “Generic Drug User Fee Amendments of 2012: Questions and Answers: Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance”. This document provides FDA responses to many questions that have been raised by industry during the...

The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug...

The USP is planning to revise their USP Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP are as follows: The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the...