The Lachman Blog

28
Jul

Real World Data and Evidence – FDA to Take Another Look

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 […]

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25
Jul

FDA issues Q&A Guidance on GDUFA Self-Identification and Other Important Issues

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 administration of GDUFA I. […]

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25
Jul

Proposed Labeling Rule Shifts to Long Term Action on HHS/FDA Agenda

The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted […]

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19
Jul

Public Meeting on Balance of Hatch-Waxman – Some Observations

On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”.  The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help […]

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17
Jul

MaPP Revision for Publication of Drug Product Approval Information

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 approvals”, […]

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12
Jul
Is Your Instrumentation Qualified for Intended Use Image

Is Your Instrumentation Qualified for Intended Use?

The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> 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 instrument. In addition, the […]

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10
Jul

Firm Decides to Remove Opana ER from the Market – What Do I Know?

On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations. During the presentation, I was   asked by […]

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06
Jul

Pharmacy Compounding in The News Again

Congress has introduced the Compounded Drug Access Bill, H.R. 2871.  This blog article only addresses the first four sections of H.R. 2871, “Preserving Patient Access to Compounded Medications Act of 2017”. Here we go again with another introduced bill for pharmacy compounding. This six-page bills title (above) purports to “preserve” patients’ access to compounded drugs […]

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