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FDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Muhammad Asim Niazi
August 22, 2025
OOS results?? fall outside acceptance criteria and trigger ??mandatory investigations??. The process has ??two phases??: initial laboratory assessment for errors, then a full-scale investigation for root cause. The ??quality unit?? evaluates evidence and
Recent Job Cuts in FDA and other pharmaceutical companies, and the impact on the industry Muhammad Asim Niazi
May 15, 2025
The pharma industry faces downsizing in various areas, where a number of employees are fired or relieved of their duties.In addition to the manufacturing industry, the FDA also faces job and funding cuts.
New FDA Regulations in the Year 2024 Muhammad Asim Niazi
January 07, 2025
The United States FDA regulates pharma drug products manufactured or marketed in the United States. There are many different functions of the FDA, and one of them is devising new regulations.
What are the FDA guidelines for contract packaging Muhammad Asim Niazi
October 18, 2024
More and more pharmaceutical product manufacturers are considering contract packaging, specifically those who can’t afford to develop a manufacturing site or are tackling higher production requirements.
Amidst contentious debates, what path will the FDA take with accelerated approvals? Krebs Qin
May 06, 2024
Accelerated approval is a privilege that every applicant desires.
Johnson & Johnson’s Balversa therapy finally gets full FDA approval Shem Oirere
March 05, 2024
The approval by the Federal Drug Agency of the bladder cancer therapy Balversa has taken a notch higher the search for more treatment options.
Brief Summary of FDA Quality Management Maturity Program Muhammad Asim Niazi
March 05, 2024
United States FDA has a pivotal role in providing guidance for pharmaceutical quality attributes and defining new ways to improve the quality by publishing new regulations for quality enhancement.
Case study of FDA warning letters Muhammad Asim Niazi
January 23, 2024
A warning letter is a part of communication by the FDA with the manufacturer to share their finding to remove the discrepancy found during their inspection and inform the status of the manufacturer's measures.
Chinese Produced ASO Drug Innovation Therapy for Functional Cure of Chronic Hepatitis B Has Obtained FDA Clinical Approval Xiaoyaowan/Pharmasources
September 08, 2023
Recently, Haobo Pharmaceuticals announced that their investigational antisense oligonucleotide (ASO) drug AHB-137 has received clinical trial approval from the FDA in the United States for use in patients with chronic hepatitis B.
Astellas’ non-hormonal VMS therapy gets FDA approval SHEM OIRERE
June 08, 2023
U.S. Food and Drug Administration has approved Veozah, the first neurokinin 3 receptor antagonist, to treat moderate to severe vasomotor symptoms.