Standards & Regulations

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.
Jul 12, 2017
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
Jul 12, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 11, 2017
By Pharmaceutical Technology Editors
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
Jul 10, 2017
By Pharmaceutical Technology Editors
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
Jul 10, 2017
By Pharmaceutical Technology Editors
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
Jul 10, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 05, 2017
By Pharmaceutical Technology Editors
ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.
Jul 05, 2017
By Pharmaceutical Technology Editors
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
native1_300x100
lorem ipsum