Regulatory Watch

Oct 05, 2017
By Pharmaceutical Technology Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Oct 02, 2017
Pharmaceutical Technology
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Sep 02, 2017
Pharmaceutical Technology
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Aug 02, 2017
Pharmaceutical Technology
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Jul 02, 2017
Pharmaceutical Technology
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
Jul 02, 2017
Pharmaceutical Technology
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jun 02, 2017
Pharmaceutical Technology
Approval of breakthrough therapies requires expedited quality assessment.
Jun 02, 2017
Pharmaceutical Technology
The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
May 08, 2017
Pharmaceutical Technology
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
May 02, 2017
Pharmaceutical Technology
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
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