Opinion - The FDA’s data on mifepristone can’t be trusted — here’s why

For the review to withstand the necessary scrutiny it will face upon publication, the FDA must prioritize robust, real-world ...
BioSpace

FDA imposes import alert on Indian plant after inspectors flag GMP failings

Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an ...
RAPS

Data integrity is ‘biggest issue’ for drug, API firms during inspections, FDA official says

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...
Hosted on MSN

FDA review panel challenges Amgen's Tavneos approval on efficacy, data grounds

The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...

US FDA flags manufacturing and data integrity lapses at Dabur India plant

The US FDA has issued a Form 483 to Dabur India following an inspection of its Dadra and Nagar Haveli plant. Discover the serious findings, including data integrity lapses, ...
JD Supra

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...
Regulatory Affairs Professionals Society

FDA cites companies for CGMP violations, telehealth firms for illegally marketing GLP-1 drugs

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to ...

This Drug Patent Bill Would Hurt Innovation Without Lowering Prices

This week, the Senate HELP Committee will consider several bills that aim to “make health care more affordable and accessible ...
Fierce Pharma

FDA hearing on Amgen's Tavneos will include findings from an independent review

An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing with the FDA which ...

U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plant

FDA highlights data integrity and contamination risks at Dabur India's plant, following a January inspection revealing ...
JD Supra

Addressing Data Integrity Challenges in Medical Device Submissions

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...