Standards/Regulations

Aug 02, 2017
Pharmaceutical Technology
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Aug 01, 2017
Pharmaceutical Technology
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Aug 01, 2017
By Pharmaceutical Technology Editors
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
Aug 01, 2017
By Pharmaceutical Technology Editors
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
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.
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