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EMA/FDA

FDA approves two hepatitis C drugs for pediatric patients

April 7, 2017 - The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children…

EMA: Reporting irregularities that may affect medicines

EMA Board adopts new policy on handling information on alleged improprieties from external sources The European Medicines Agency’s (EMA) Management Board has adopted a new policy on how EMA handles…

US drugs regulatory process faster than European agency’s

The US regulator, the Food and Drug Administration (FDA) reaches its decisions more quickly than its European counterpart, the European Medicines Agency (EMA), finds an analysis* published in a letter…

Optimising safety information for medicines in Europe throughout product lifecycle

New guidance and process improvement for periodic safety update reports Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update…

EU rapid drug approval plan worries some national agencies

A push by the European Medicines Agency to speed up the approval of new drugs that show promise is running into resistance from some of the national agencies that will…

Mylan receives tentative approval for “TLE400” under PEPFAR

TLE400 is a fixed-dose combination containing efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400 mg/300 mg/300 mg HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017 -- Mylan N.V. (NASDAQ, TASE: MYL),…

Romania bids to host EU drug agency after Brexit

Romania wants Brussels to relocate its pan-European drug regulator EMA to Bucharest from London after Brexit, the government said on Wednesday, hoping that the fact that it still hosts no…

Trump chooses Gottlieb to run FDA; Pharma breathes sigh of relief

U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the…

Atazanavir Mylan approved for use in Europe

Atazanavir Mylan, a generic version of Reyataz, has been granted a marketing authorisation for use in the European Union. For more information, click here.

European and US regulators agree on mutual recognition of inspections of medicines manufacturers

Transatlantic agreement will help to make better use of inspection capacity and reduce duplication Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections…