The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety...
Archive for category: Regulatory Affairs
FDA issues guidance to support the responsible development of nanotechnology products
Pharma Live, , Regulatory Affairs, 0Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory...
EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications
Pharma Live, , Regulatory Affairs, 0The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint...
European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
Pharma Live, , Regulatory Affairs, 0The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share...
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
Regulation For Nutraceuticals in India – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The Food Safety and Standards Authority of India, some time back, had set up a task force to put...
Indian Pharmacy Practise Regulations 2015 – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The government of India last January issued a notification entitled Pharmacy Practice Regulations 2015 aimed at enhancing the status...
Scottish cost regulators OK NHS use of 7 new drugs – Courtesy (Pharma Times)
Pharma Live, , Regulatory Affairs, 0The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment...
Drug Regulator Fixes Prices of 30 Formulation Packs in India – Courtesy (NDTV)
Pharma Live, , Regulatory Affairs, 0The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 30 formulation packs, including drugs used to treat various...
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