An FDA Perspective on Decentralized Clinical Trials: Part II

With decentralized clinical trials (DCTs), what responsibilities fall under sponsor oversight? At the

An FDA Perspective on Decentralized Clinical Trials: Part I

During the recent pandemic, as with many facets of life and business, the design and conduct of clinical

From Data Integrity to Data Culture

The Critical Role of Management Engagement in Quality Culture What can regulatory documents and FDA

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a. LUPIN, located in

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: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including

Instant Download | Yes, Warehouses Must Comply with Relevant GMPs

In November 2019 FDA issued an unusual warning letter to Greenbrier International Inc (doing business as

Instant Download | FY2020 and FY2021 Drug GMP Warning Letter Analysis

It has been an interesting two years, to say the least! We have seen unprecedented upheaval in FDA

Webinar – A Fresh Take on Pre-Approval Inspection Data

Webinar – FDA GCP Inspection Trends Identified Using AI

Webinar – Are Laboratories Perpetuating Data Integrity Problems?

Report – 4 GMP Case Studies Including FDA Findings and Concerns

Report – Analysis of 2021 U.S FDA 483 GMP Observations

Report – Yes, Warehouses that Store and Distribute FDA Regulated Products Must Comply with Relevant GMPs

Assessment – Investigator Snapshot

Assessment – Benchmark Report

Assessment – 483 Observation Report