Industry Awaits Two Important OGD/OPQ Documents – Keep the Faith?

During the Hatch-Waxman meeting recently held at FDA headquarters, the new Commissioner alluded to two documents that he pledged would be issued hopefully by the end of this year.  One was a Good ANDA Assessment MaPP and the other a Good ANDA review Practices document.  In reviewing the history of the industry complaints regarding inconsistent reviews,

Don’t Guess Any Longer! Read the Guide on Ex-Date for Unit Dose Repackaged Products

For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.  (see full guidance here). 

Pharmacy Compounding in the News Again – Difficult to Compound List – A Long Time Coming

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 Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).  

Child-Resistant Packaging – FDA Issues Labeling Guidance

The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers.  Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.

User Fee Bills Need to be Paid but Reauthorization of User Fees Needs to be Passed – SOON!

FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures.  Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees. 

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.

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 to long-term actions on the HHS unified agenda (here). 

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 ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”

While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar. 

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”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014. 

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:

  1. 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.