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FDA Flags “Testing Into Compliance”; Auriga Warning Letter Exposes Quality Unit Failures

Auriga Research Pvt. Ltd. has received an FDA Warning Letter after a February 2026 inspection of its contract testing laboratory in Bengaluru, India. FDA cited significant CGMP violations involving incomplete laboratory records, weak Quality Unit oversight, and OOS investigations based
  • News
FDA Flags “Testing Into Compliance”; Auriga Warning Letter Exposes Quality Unit Failures

Pharmaceutical Legislation in India in 2026: CDSCO, Drugs and Cosmetics Act, Schedule M, and NDCTR Guide

India’s pharmaceutical regulatory system is evolving through stronger CDSCO regulations, revised Schedule M requirements, risk-based inspections, and updated approval controls. This guide explains the key laws, authorities, licensing requirements, and compliance expectations pharmaceutical professionals need to understand in 2026.
  • Blog, Quality Management System
Indian pharma legislation showing CDSCO regulations, GMP manufacturing, regulatory documents, inspections, and quality compliance controls.

No New Clinical Concerns; GMP Issues Still Block Dasynoc’s FDA Review

Xspray Pharma has received another Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Dasynoc. This time, the remaining issues center on GMP observations at third-party manufacturer NerPharMa and additional data from consecutive commercial-scale batches. Xspray still
  • News
No New Clinical Concerns; GMP Issues Still Block Dasynoc’s FDA Review

Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

Senior quality leaders from Gilead Sciences, Pfizer and GSK used the Bioprocessing Summit in Boston to caution pharmaceutical companies against rushing weak processes into digital and AI systems. Their message was consistent: digital technology can improve quality operations, but poorly
  • News
Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

Pharmaceutical Legislation in the EU in 2026: New Pharma Reform, EMA Rules, Marketing Authorization, and GMP Compliance

Explore how EU pharmaceutical legislation reform, EMA regulatory requirements, marketing authorisation, and EU GMP expectations are reshaping pharmaceutical compliance. This article explains the legal framework, post-approval variations, manufacturing controls, inspection readiness, and the key changes companies should monitor.
  • Blog, Quality Management System
European pharma legislation visual showing EMA regulatory requirements, marketing authorisation, EU GMP compliance, and pharmaceutical manufacturing oversight.

FDA Warning Letter Flags OOS Averaging; Confirmed OOS Still Led to Batch Release

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to ABS Corporation, a veterinary drug manufacturer in Omaha, Nebraska, after a January 2026 inspection identified significant CGMP violations involving OOS investigations, incoming component testing, and process validation.
  • News
FDA Warning Letter Flags OOS Averaging; Confirmed OOS Still Led to Batch Release

EMA Flags Tavneos Trial Breaches; EU Revokes Approval Over Data Integrity

European regulators have revoked Tavneos’ marketing authorization in the EU and EEA after finding serious problems in how data from its pivotal ADVOCATE study were handled. The EMA concluded that the study could no longer reliably demonstrate efficacy after unblinded
  • News
EMA Flags Tavneos Trial Breaches; EU Revokes Approval Over Data Integrity

Pharma Legislation in 2026: Drug Approval, GMP Requirements, Pharmacovigilance, and Global Compliance Guide

Explore how pharmaceutical regulations shape drug development, marketing authorization, GMP requirements, and pharmacovigilance across major markets. This guide explains global regulatory frameworks, approval pathways, compliance expectations, and inspection readiness for pharmaceutical companies operating under changing regulatory requirements.
  • Blog, Quality Management System
Global pharmaceutical regulatory framework showing GMP regulations, marketing authorization, regulatory authorities, and compliance monitoring.

27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

Shilpa Medicare is voluntarily recalling more than 27,000 vials of Pemetri RTU chemotherapy drug in the United States after market complaints reported green to dark-green discoloration in certain vials. The nationwide action involves two strengths and has been classified by
  • News
27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Capricor Therapeutics plans to amend its BLA for deramiocel after an FDA advisory committee voted 9–3 against finding substantial evidence of effectiveness for Duchenne muscular dystrophy cardiomyopathy. During its August 13 earnings call, the company said the amendment will add
  • News
FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path