2020 FDA Combination Products Policy and Guidance Changes
Combination products—combinations of drugs, biologics, or devices that are physically, chemically, or
FDA OMQ Regulatory Actions Increase Dramatically in FY2020
While the number of drug GMP warning letters declined by about 30% in FY2019, the number of import
Ashley Boam on FDA’s Proposed Quality Maturity Model
FDA is proposing the use of a model that would measure and rate the maturity of a pharma company
OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns
December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.
FDA Warning Letters Weeks of 11/22/2020 & 12/1/2020: Water Leaks, Misleading Statements, & Adulteration
The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter
FDA Warning Letters Week Of 11/8/2020: Unapproved Cord Blood Product & No Process Validation
Of the two drug-related FDA Warning Letters issued last week, one, issued to a homeopathic drug
Trends & Analysis
How to Identify Data Integrity (and Other) Trends
Why should firms review regulatory noncompliance data? What useful information can be gained via
An Update On 503B Outsourcing Facilities
In response to the 2012 fungal meningitis outbreak that occurred at the New England Compounding Center
Data Integrity 101: Why is it Important?
In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology,
Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.