Standards & Regulations

Aug 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes; President Trump signs legislation.
Aug 04, 2017
By Pharmaceutical Technology Editors
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
Aug 02, 2017
Pharmaceutical Technology
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
Aug 02, 2017
Pharmaceutical Technology
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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.
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