The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety...
Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory...
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint...
The 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...
The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
The Food Safety and Standards Authority of India, some time back, had set up a task force to put...
The government of India last January issued a notification entitled Pharmacy Practice Regulations 2015 aimed at enhancing the status...
The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment...
The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 30 formulation packs, including drugs used to treat various...
