Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets.  The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in the day than the reference listed drug product (and/or authorized generic). 

Compounding Pharmacies – Still in the Cross Hairs

Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection.  However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to 503A (43 total) and 503B (37 total),

Getting a CRISPR View – Genetic Editing: Medical Frontier

Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”.  Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells.  While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted therapy uses drugs or other specially created substances (e.g.,

What Was Old is New Again

Thirty-six years ago as a young Pharmacy post-graduate, I was introduced to the “Continuous Process”. Merck commissioned the plant housing this process in the late 1970’s in the Shenandoah Valley of Virginia. Building on the company’s experience with continuous chemical processing, the plant manufactured a blockbuster (at the time) anti-hypertensive “Aldomet”, Methyldopa Tablets, USP. At the peak of production,

First it Was Natural and Now it is Healthy – Your Comments, Please

After receiving thousands of comments on what the term “natural” should mean with regards to foods (see previous post here), the FDA is now reexamining the term “healthy” in food labeling.  In addition, they also released an immediately effective guidance to describe their thoughts on their proposed enforcement discretion relative to the use of the term.

Window into GDUFA II Outlined in Federal Register Notice

Well the negotiations for GDUFA II are completed, but what is in the works?  This morning a Federal Register Notice (FR) published announcing a public meeting on GDUFA II, but the notice itself provides some insight to the changes coming in GDUFA II and some big changes are coming.  The FDA plans to release its GDUFA II commitment letter (the bible of GDUFA) that will provide additional details on the program changes prior to the public meeting on October 21,

Self-Identification Guidance for Generic Facilities Issued by FDA

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA.  This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish.  The document also discusses which of the facilities, sites,

Data Governance – Establishing a Path Forward to Assure Data Integrity

Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety.  Companies are in a frenzy responding to regulatory citations and preparing for inspections.  The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated through a number of recent guidances (drafts,

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes:

  • Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA ** –

Follow-up on New Final Rule for Drug Listing and Establishment Registration

After slogging through the 200+ pages of the Final Rule, here is a partial list of some of the comments I found interesting or that explain some of the changes or comments along with a summary of the FDA response from the Final Rule (here).

Comment 9 – Clarification of importers requirement to identify every entity it delivers product to will be narrowed in scope to the “importer”

19 Consumer Antiseptic Wash Ingredients Found Not to Be GRAS/GRAE

The FDA published a Federal Register (FR) notice today declaring that 19 ingredients for use in consumer antiseptic wash (use with water to wash off) are not generally recognized as safe and effective (GRAS/GRAE).  The Agency has however deferred a decision on three additional ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) for this use as additional studies and data are being reviewed at this time to support an Agency finding.

202 Page FR Notice – Final Rule for Revised Drug Listing and Manufacturers Registration, Take Note!

Have some spare time on your hands?  Read the new Final Rule that FDA pre-published today (here) .  FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in conformance with section 510 of the Federal Food,

Follow-up on PIC/S Data Integrity Guidance

We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a regulatory agency Guidance document.

PIC/S Draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”

 It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection by ensuring the data is “…complete,