Standards & Regulations

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.
Jul 17, 2017
By Pharmaceutical Technology Editors
The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.
Jul 13, 2017
By Pharmaceutical Technology Editors
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
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