All drug regulation articles
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ResearchTen years on, pharma industry still testing for implausible alkyl sulfonate ester contaminants
Risk assessment for potential mutagenic side-products is still required by regulatory bodies, despite lack of evidence they form during drug production
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NewsTelemedicine abortion provider locks horns with US drug regulator
Food and Drug Administration urged to take action against abortion charity by US politicians
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ReviewBitter Pills: The Global War on Counterfeit Drugs
Muhammad Zaman’s book gives an account of the challenges facing drug regulators worldwide
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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
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ResearchDietary supplement poisoning every 24 minutes in the US
275,000 calls concerning supplements were made to poison centres between 2002 and 2012
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Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
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BusinessFemale sexual desire drug approved
Concerns raised over efficacy, side effects and use of advocacy campaigning to influence regulatory decisions
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BusinessIndian pharma under increased regulatory scrutiny
Import bans and tightened rules pose a significant challenge for companies
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Business
Injunction blocks first US biosimilar
Despite regulatory approval, Amgen is delaying sales of Sandoz’s version of filgrastim
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Business
Drug firms warned to be honest with investors
Official warns of ‘significant consequences’ if companies aren’t forthcoming about their FDA interactions
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BusinessPrice caps provoke lawsuits from Indian pharma industry
New government controls on cardiovascular and diabetes drugs challenged by industry lobby groups
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News
Radical drug rule changes hit buffers in India
Oversight panel concludes government plan will increase bureaucracy
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Business
US turnaround on Avandia restrictions
Researchers accuse regulator of face-saving U-turn over diabetes medication safety
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NewsIndian supreme court’s anger over unregulated clinical trials
Tales of collusion between drug companies and regulators leads court to criticise the government
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BusinessInterview: EMA head Guido Rasi
Guido Rasi, head of the European Medicines Agency, wants to see greater transparency in drug development
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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
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BusinessDrug watchdogs mark out global territory
US and European regulatory agencies are leading worldwide collaborations to ensure drugs from outside their borders are safe