BioPharma Consulting Group Launches Advisory Framework for AI Regulatory Expectations

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

Part 11, Data Integrity & Documentation for SaaS/PaaS Validation Training Webinar (Jan 26, 2026 and On-Demand)

This course offers an essential opportunity to enhance data integrity and compliance for cloud systems. It provides a practical model for documentation and change control, crucial for meeting ...

CSA in Practice Training Webinar: How to Build Defensible Evidence the FDA Actually Wants to See (ONLINE EVENT)

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...
NDTV Profit on MSN

Cipla shares fall 4% after USFDA flags compliance issues at Pharmathen's Rodopi facility

The form includes nine observations highlighting serious concerns over current Good Manufacturing Practices (cGMP).

Digital Validation and Cloud Assurance Modular Course for Practitioners: Validating SaaS, PaaS and Automated Pipelines under CSA (Jan 21st - Jan 26th, 2026)

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

Third Time's The Charm: Outlook Therapeutics' Lytenava Heads To FDA, Again

Outlook Therapeutics faces a pivotal FDA decision for Lytenava on December 31st, following two prior rejections. Read why ...

The FDA often doesn’t test generic drugs for quality concerns, so ProPublica did

The post The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did appeared first on ProPublica.
FiercePharma

FDA outlined concerns with Elevidys' manufacturing at Catalent site, Form 483 shows

Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA filings ...
ProPublica

How We Created a Tool That Tells You Where Your Generic Drugs Were Made

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Join us Jan. 14 for a virtual discussion about our Rx ...
BioSpace

Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections. When the FDA asked manufacturers about ...
Fox Business

FDA rolls back 'red tape' in move aligned with Trump push to speed up new cures

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...
The Business Journals

Violations at Raleigh plant dent pharma company's financial outlook

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The company cut its revenue ...