Standards & Regulations

Jul 28, 2017
By Pharmaceutical Technology Editors
The agency is asking public consultation on the concept paper.
Jul 28, 2017
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 25, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
Jul 25, 2017
By Pharmaceutical Technology Editors
Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
Jul 21, 2017
By Pharmaceutical Technology Editors
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
Jul 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Jul 18, 2017
By Pharmaceutical Technology Editors
The agency cited the Italian company for aseptic processing failures.
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