All drug regulation articles
-
NewsTelemedicine abortion provider locks horns with US drug regulator
Food and Drug Administration urged to take action against abortion charity by US politicians
-
ReviewBitter Pills: The Global War on Counterfeit Drugs
Muhammad Zaman’s book gives an account of the challenges facing drug regulators worldwide
-
NewsFears that US 'right to try' law could put patients at risk
Legislation will give terminally ill patients the option of taking medicines that have had little testing
-
ResearchDietary supplement poisoning every 24 minutes in the US
275,000 calls concerning supplements were made to poison centres between 2002 and 2012
-
Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
-
BusinessFemale sexual desire drug approved
Concerns raised over efficacy, side effects and use of advocacy campaigning to influence regulatory decisions
-
BusinessIndian pharma under increased regulatory scrutiny
Import bans and tightened rules pose a significant challenge for companies
-
Business
Injunction blocks first US biosimilar
Despite regulatory approval, Amgen is delaying sales of Sandoz’s version of filgrastim
-
Business
Drug firms warned to be honest with investors
Official warns of ‘significant consequences’ if companies aren’t forthcoming about their FDA interactions
-
BusinessPrice caps provoke lawsuits from Indian pharma industry
New government controls on cardiovascular and diabetes drugs challenged by industry lobby groups
-
News
Radical drug rule changes hit buffers in India
Oversight panel concludes government plan will increase bureaucracy
-
Business
US turnaround on Avandia restrictions
Researchers accuse regulator of face-saving U-turn over diabetes medication safety
-
NewsIndian supreme court’s anger over unregulated clinical trials
Tales of collusion between drug companies and regulators leads court to criticise the government
-
BusinessInterview: EMA head Guido Rasi
Guido Rasi, head of the European Medicines Agency, wants to see greater transparency in drug development
-
Business
Roche rapped for side-effect reporting failure
European medicines regulator names and shames Swiss giant for not disclosing 80,000 instances of potential adverse drug reactions
-
BusinessDrug watchdogs mark out global territory
US and European regulatory agencies are leading worldwide collaborations to ensure drugs from outside their borders are safe