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August 02, 2017
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies.
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
August 01, 2017
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
July 25, 2017
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
July 21, 2017
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.
July 18, 2017
The agency cited the Italian company for aseptic processing failures.
July 17, 2017
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.
July 13, 2017
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.