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). 

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). 

It’s Official – OGD Sets Record for Approval Actions

In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the highest total of total approval actions (100) in a month,

By My Count, A New OGD Approval Record Set in June

With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017.  From data gathered from the daily approval report, I find at least 84 full ANDA approvals,

Enforcement Date Rolled Back One Year for Elements of Drug Supply Chain Security Act

FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers  The guidance explains what a product identifier is and how enforcement discretion will be applied.