ICH Offers Updates on Guidelines, Working Groups

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...
Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...
India Adds Four Medical Device Types to CDSCO List of Regulated Products

India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on its Sugam online portal. The consultation is designed to ascertain how users feel...
FDA to beef up cell and gene therapy staff

International – FDA to Follow EMA With Move From London to Amsterdam

As the US Food and Drug Administration (FDA) now communicates with its European counterparts on a daily basis, the US agency has decided to...
Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can...
Mylan recalls 15 lots of blood-pressure drug containing valsartan

International – Mylan recalls 15 lots of blood-pressure drug containing valsartan

Mylan (NASDAQ:MYL) starts a voluntary U.S. recall of select lots of Valsartan-containing products due to trace amounts of an impurity that's classified as a probable human...
Intracranial Hemorrhage Detection Software Receives FDA Clearance

International – Pfizer to increase some drug prices in 2019

Pfizer announced Friday it is raising the prices of dozens of drugs in 2019 after bowing to pressure earlier this year from President Donald Trump and...
Nouveau glossaire des dénominations communes des ingrédients (INCI) (Projet de texte établi conformément au règlement cosmétique 1223/2009)

International – EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday...
Australia and Canada Extend Mutual Recognition Agreement to APIs

International – Australia and Canada Extend Mutual Recognition Agreement to APIs

Australia and Canada have expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs). The change means TGA will accept good manufacturing...
GSK’s says depot HIV injection works over three years

International – GSK’s says depot HIV injection works over three years

GlaxoSmithKline’s bid to develop an alternative to daily dosing of HIV drugs has made further progress, with new data backing the efficacy of a...

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