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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.
Thrombolytic Science Announces FDA’s IND Clearance of Mutant Prourokinase for the Treatment of Thrombotic Diseases PharmaSources
October 15, 2024
Thrombolytic Science, LLC (TSI), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme.
Remote Inspections in the pharmaceutical industry Muhammad Asim Niazi
May 09, 2024
The global pandemic of COVID–19 changed the thinking and behavior of many people and industries, and they were forced to work from home.
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.
The Narrative of Pharmaceuticals Bestowed with Endorsement and Later Reclaimed by Oblivion by the FDA zhulikou431
March 06, 2024
This document endeavors to compile and elucidate data pertaining to instances where the U.S. FDA, in recent years, has rescinded market approval for pharmaceuticals previously sanctioned.
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.
New regulations in the Year 2023 for different regulatory bodies around the world Muhammad Asim Niazi
January 23, 2024
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
How is the progress of China’s domestically produced PD-(L)1 “going global”? Yefenghong/PharmaSources
November 23, 2023
Recently, Coherus BioSciences announced that the FDA has approved the launch of PD-1 antibody toripalimab (marketed jointly by Junshi Biosciences and Coherus) for use in combination with gemcitabine/cisplatin as a first-line treatment for advanced recurre

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