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

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,

Webinar – General Announcement Campaign – P

Webinar – The Ecosystem for Smart Combination Products: What About Regulations

Webinar – Introducing the New Enforcement Analytics

Report – Special Report from the FDLI Enforcement, Litigation, and Compliance Conference

Report – FY2018 Drug GMP Warning Letters

Report – State of Pharmaceutical Quality

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report