Header graphic for print
Focus on Regulation

Tag Archives: draft guidance

MHRA Publishes Draft Guidance on GxP Data Integrity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which includes definitions of key terms. The draft Guidance applies to both paper and electronic data in all areas of GxP (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state

Recent First Amendment Rumblings

Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications.  Here are some of the developments we’ve been following: In April:  CDER Director Janet Woodcock noted in her remarks at the FDLI Annual Conference that the agency is “currently evaluating our advertising policies in light of first amendment

FDA Issues Simpler Draft Form for Individual Patient Expanded Access Applications

On February 4, 2015, the Food and Drug Administration (FDA) issued a new Draft Guidance titled Individual Patient Expanded Access Applications: Form FDA 3926. The Draft Guidance introduces draft Form FDA 3926, which – when finalized – may be submitted by licensed physicians to FDA for expanded access (or “compassionate use”) requests for individual patient Investigational New Drug Applications (INDs).

FDA Issues Revised Draft Guidance on Reporting Drug Sample Information Under the ACA

On July 11, FDA issued new draft guidance concerning drug sample reporting mandated under the Affordable Care Act (ACA).  The guidance, Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act, replaces agency’s earlier April 2012 guidance, Compliance Policy on Reporting Drug Sample Distribution Information.  In this new document, the agency provides more

FDA To Announce Actions Regarding Combination Products

Final Rule on Combination Product cGMP FDA today announced the release of a final rule on current good manufacturing practices (cGMP) for combination products. The rule, which will establish 21 CFR Part 4 – Regulation of Combination Products, is set for publication in the January 22 edition of the Federal Register, and will become effective

Reining in FDA’s “Expansive Language” and “Doubly Grandiose” Interpretations of Chemical Action

When the Food and Drug Administration (“FDA” or the “agency”) issued two draft guidances regarding the definition of “chemical action” and how it would relate to product designations under the FDC Act in June 2011, we argued in an FDLI Update article that the agency’s interpretation of the statute and guidances could “provide FDA with