News

Browse through latest news in Pharmaceutical GMP, Quality and Regulatory domains – Important Quality events, Regulatory events, New guidelines, New Chemical Entity (NCE) approvals..Qvents tracks several news and updates, and lists the most relevant news for pharma Tech Ops professional, chaffing out the rest.

Latest News

FDA Warning Letter to Simtra Biopharma Flags Microbial Controls, Integrity Failures, Design Issues
April 10, 2026, USFDA 483, Warning letter
FDA Publishes Warning Letter with Photos of Insanitary Conditions at Patcos Cosmetics
March 25, 2026, Qvents, USFDA 483
Zydus Novel CKD Anaemia Drug Receives China NMPA Approval
March 23, 2026, Product Approval
USFDA Approves Aurobindo Subsidiary’s NDA for Eczema Drug
February 18, 2026
Antibiotics to Carry Blue Strip Label in India
February 9, 2026, CDSCO, Drug Alerts, Guidance
USFDA Warning Letter to Chemspec Over Serious Data Integrity Violations
January 30, 2026, Warning letter
Sun Pharma Baska Facility Classified OAI for Aseptic Operation Deficiencies
January 13, 2026, Qvents, USFDA 483
USFDA 483 to Catalent Baltimore Flags Deficiencies in Aseptic Practices
January 2, 2026, Qvents, USFDA 483
USFDA Warning Letter to Catalent Indiana Following OAI Classification
December 16, 2025, Qvents, USFDA, Warning letter
FDA 483 to Favera, France Cites Gaps in Aseptic Processes, Data Integrity Risk
December 10, 2025, USFDA 483
USFDA Updates Consideration for CES for Biosimilars in Draft Guidance
November 21, 2025, Guidance, USFDA
CDSCO Directs Pharma Solvent Manufacturers to Register on ONDLS System: A Critical View
November 5, 2025, CDSCO, Drug Alerts
FDA Classifies Novo Nordisk Plant OAI, Product Approval for Regeneron, Scholar Rock Stuck
October 31, 2025, Product Approval, USFDA 483
Hetero Warehouse Flagged for Serious Lapses in Material Controls by USFDA
October 28, 2025, USFDA 483
Malta Medicines Authority Maintains cGMP Non-Compliance Statement of Akriti Pharma
October 22, 2025, EDQM, EMA
Another Cough Syrup Fiasco
October 9, 2025, Drug Alerts
FDA Announces Measures to Speed Up Review of U.S ANDAs
October 7, 2025, USFDA
Janssen Vaccine Unit Warning Letter Flags Complaint Handling, Regulatory Notifications
October 2, 2025, Qvents, Warning letter
USP Launches Whatsapp Channel
September 22, 2025
OAI Classification for Sun Pharma Halol Facility
September 11, 2025, Qvents, USFDA 483
India to Allow Manufacture of New Drugs for Clinical Trials, BA/BE Studies After Notification
September 10, 2025, CDSCO, Guidance
Japan Generics to Have Zero Percent Tariffs in U.S.
September 9, 2025, USFDA
Amneal Warning Letter Cites Fibers in PP Bags of Injectable Product, Lapses in BET testing
September 4, 2025, USFDA, Warning letter
India Makes Disclosure of Excipients on Drug Labels Mandatory
August 29, 2025, CDSCO, Guidance
FDA 483 to Catalent Indiana Flags Inadequate Investigation of Contaminants, Equipment Failure
August 25, 2025, USFDA 483
FDA Approves Insmed’s New Oral Lung Disease Drug
August 13, 2025, Product Approval
MHRA on FDA Warning Letters
August 12, 2025
EC Issues Annexure 22 – Draft Guidance For AI Systems Used in Manufacture of Medicinal Products
July 23, 2025, Guidance
Glenmark Pithampur Facility Issued USFDA Warning Letter
July 15, 2025, Qvents, Warning letter
New NSCLC Drug Approved by USFDA – China’s Drug Discovery Leap From APIs to Homegrown NMEs
July 14, 2025, Product Approval
USFDA Publishes 200+ CRLs: Gives Insights Into Common Deficiencies in Drug Applications
July 14, 2025, USFDA
FDA Extends Nitrosamine Timelines
June 30, 2025, Guidance, USFDA
CDSCO’s NSQ Alerts – May 2025: Central and State Labs Flag 186 Cases
June 25, 2025, CDSCO
USFDA Issues Final Guidance for PFC For Prioritized ANDAs
June 17, 2025, Guidance, USFDA
Yiling Pharma Warning Letter: Equipment Duct Cleaning & Cross-Contamination Issues Flagged
June 5, 2025, Qvents, Warning letter
Data Integrity Concerns: USFDA Issues Notification Citing Two Chinese Firms
May 26, 2025, USFDA
CDSCO Updates Export NOC Procedure for New Drugs
May 21, 2025, CDSCO, Guidance
Drugs Technical Advisory Board Recommend Suspension of Product Permission of NSQ Drugs in India
May 5, 2025, CDSCO, Guidance
CDSCO Publishes NSQ Drugs List for March 2025
May 2, 2025, Drug Alerts
Veterinary Injection Recall Due to Particulate Matter by Cronus Pharma
April 30, 2025, Recall
USFDA 483 for Glenmark Facility Highlights Cleaning Failures and Beta-Lactam Contamination Risks
April 30, 2025, USFDA 483
More Lots of Antidepressant Drug Recalled Due to N-Nitrosoduloxetine
April 25, 2025, Nitrosamines, Recall
USFDA Announces Second Quality Management Maturity Assessment Program
April 24, 2025, Upcoming Events
WHO Publishes Comprehensive Guidelines for Control of Nitrosamines in Pharmaceuticals
April 18, 2025, Guidance
CDSCO Not of Standard Quality Drug Alert for February 2025
April 9, 2025, Drug Alerts
FDA Issues Warning Letter to Aspen Biopharma’s API Facility in Hyderabad
April 3, 2025, USFDA, Warning letter
CDSCO Notifies New Online Export NOC System
April 1, 2025, Guidance
FDA Approves Sanofi’s New Hemophilia Drug
April 1, 2025, Product Approval, USFDA
FDA Issues Repeat Warning Letter to Thailand-Based OTC and Cosmetics Manufacturer, International Laboratories
March 25, 2025, Warning letter
Strides Recall Several Lots of Topical Gel Due to Benzene Concerns
March 17, 2025, Guidance, Recall
Glenmark Recalls Over 1.5 Million Bottles of ADHD Drug for Nitrosamine Impurity
March 3, 2025, Nitrosamines, Recall
USFDA Issues Warning Letter to Global Calcium
February 17, 2025, USFDA, Warning letter
FDA Issues Warning letter to Chinese API Manufacturers, Wuhu Nuowei & Chengdu Innovation
February 12, 2025, USFDA, Warning letter
Timeline for Revised Schedule M Implementation Extended to December 2025
January 30, 2025, CDSCO, Guidance
CDSCO Drug Alert: Assay, Dissolution Failures, and Particulate Matter Dominate Quality Concerns
January 27, 2025, Drug Alerts
Sanofi’s API Facility in US Issued Warning Letter
January 23, 2025, Qvents, Warning letter
FDA Issues New Guidance on 21 CFR 211.110: Key Points and Considerations for Industry
January 11, 2025, Guidance, USFDA
FDA Warning Letter to Indoco Remedies Flags Lapses in Microbiological Testing, Aseptic Facilities
January 10, 2025, USFDA, Warning letter
USFDA Warning Letter to Akron Formulations Flags BCC Contamination Risks and Use of APIs Under Import Alert
January 7, 2025, Warning letter
CDSCO Flags Spurious and Poor Quality Drugs for November 2024
December 31, 2024, Drug Alerts
One More Drug Recall for NDSRI From Glenmark
December 26, 2024, Nitrosamines, Recall
USPTO Withdraws Proposed Rule Targeting Terminal Disclosures
December 23, 2024
FDA Approves New Skin Cancer Drug
December 18, 2024, Product Approval
FDA Approves New Drug for Control of Androgens.
December 17, 2024, Product Approval
Major Recall of Aurobindo’s Anti-Depressant Drug for Nitrosamine NDSRI, N-Nitroso-duloxetine
December 10, 2024, Nitrosamines, Recall
CDSCO Issues Spurious Drug Alert for Popular Antibiotic, Acidity and Cholesterol Drugs
December 3, 2024, CDSCO, Drug Alerts
EC General Court Refuses to Extend Suspension of Ocaliva Revocation
November 28, 2024, Drug Alerts
USFDA Flags Major cGMP Deviations at Unexo Life Sciences: 15 Million Medicated Patches Recalled
November 25, 2024, Recall, Warning letter
NDSRI Nitrosocinacalcet: Aurobindo Recall Batches After DRL, Accord
November 21, 2024, Nitrosamines, Recall
Delaying, Denying, Limiting, Refusing Inspection: Chinese Mfr Tianjin Darentag Issued FDA Warning letter
November 20, 2024, Warning letter
Oral Phenylephrine Not Effective: FDA Proposes Removal
November 11, 2024, Drug Alerts, USFDA
USFDA 483 to Novo Nordisk Cite Lapses in Production Records, Water Quality Testing
October 30, 2024, USFDA 483
New FDA Guidance: Review of DMFs in Advance for ANDA Submissions
October 29, 2024, Guidance
CDSCO Quality Alert for 67 Medicines in September 2024
October 25, 2024
CDSCO Flags Spurious Drugs of PAN D, Urimax D, Shelcal
October 24, 2024
Intas Recall Cisplatin Injection For Impurities
October 14, 2024, Recall
FDA approves Roche’s Inavolisib for Breast Cancer
October 11, 2024, Product Approval
EMA To Review Finasteride and Dutasteride Over Concerns of Suicidal Thoughts
October 7, 2024, EMA
Spurious Drugs Linked to Sun Pharma, Glenmark, and Macleods: CDSCO Update
October 1, 2024, CDSCO, Drug Alerts
CDSCO Drug Alert for August 24
September 24, 2024, CDSCO, Drug Alerts
FDA Updates Guideline for Control of Nitrosamines
September 20, 2024, Guidance, Nitrosamines
USFDA Issues Warning Letter to Zydus: Flags Cross Contamination Risks, Poor Aseptic Techniques
September 13, 2024, USFDA, Warning letter
Ocaliva: EC Withdrawal of Approval Temporarily Suspended
September 9, 2024, Drug Alerts
CDSCO Alert: Baxter Recalls Fibrin Sealant Tisseel in India
September 3, 2024, Drug Alerts, Recall
CDSCO NSQ Drug list: Failure for Dissolution and Assay in Majority of Drugs
August 30, 2024, Drug Alerts
Dr.Reddy’s Recall Several Lots of Ibuprofen Tablets for Impurities
August 28, 2024, Recall
FDA Approves New Molecular Entity Lazertinib for Lung Cancer Treatment
August 23, 2024, Product Approval
CDSCO Consider Bringing Good Distribution Practice Guidance into Schedule
August 19, 2024, CDSCO
FDA approves Gileads Liver Drug Livdelzi (Seladelpar) for PBC
August 18, 2024, Product Approval
FDA Announces FY 25 GDUFA Rates, ANDA Fee See Steep Hike
August 5, 2024, USFDA
Failure to Report Changes: South Korea MFDS Penalises GSK
July 31, 2024
Zydus Recall Verapamil Hydrochloride for Cross Contamination
July 23, 2024, Recall
CDSCO Alert for Poor Quality of Medicines
July 2, 2024, CDSCO, Drug Alerts
Deficient Method Validations, Aseptic area controls – Concerns in USFDA 483 to Cipla
June 30, 2024, USFDA 483
Glenmark Recall 114 Batches of Potassium Chloride Capsules in US
June 27, 2024, Recall
FDA Final Guidance: Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
June 26, 2024, Guidance, USFDA
FDA 483 to DRL : Issues in Analytical Validation, Process Validation, Investigations
June 24, 2024, USFDA 483
CEP for Sterile Drug Substances: EDQM issues Draft Guidance for Content of Dossier
June 20, 2024, EDQM, Guidance
FDA issues Guidance on Facility Readiness Goal Date Decisions
June 19, 2024, Guidance, USFDA
Two more Product Recalls by Eugia for Impurities
June 18, 2024, Recall

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