Regulatory Watch

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.
Apr 03, 2017
Pharmaceutical Technology
Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.
Apr 02, 2017
Pharmaceutical Technology
Industry fears limited benefits as FDA readies voluntary data tracking program.
Mar 02, 2017
Pharmaceutical Technology Europe
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
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