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CLINICAL TRIALS RULES
Forget the DOJ. For a Trump pardon, call "Bobby" and other influencersPresident Donald Trump's pardon system has shifted dramatically. Influence now hinges on personal networks and narratives of victimhood, by...
Drug companies directed to step up vigil on adverse reactionsIndia's drug regulator, CDSCO, has mandated all drug companies to establish systems for tracking adverse drug reactions. This move comes am...
Serum Institute of India to manufacture Oxford Ebola vaccine backed by $8.6 million CEPI fundingSerum Institute of India will produce clinical trial doses of a new Ebola vaccine from Oxford University. This initiative is backed by fres...
Moderna and other groups get $60 million to develop Ebola vaccineCEPI is investing around $60 million to speed up the creation of vaccines against the deadly Ebola Bundibugyo virus. This funding will supp...
Quote of the Day by Franz Kafka: 'You can hold yourself back from the sufferings of the world, that is...'—Top quotes by the Absurdist fiction novelist, author of The MetamorphosisQuote of the Day: Franz Kafka, a renowned writer, explored themes of isolation and anxiety. His quote suggests that avoiding the world's su...
Forget 10,000 steps: Scientists say this specific daily number is all you actually need to stop weight from coming backWeight loss: A new study is challenging the popular “10,000 steps a day” rule, suggesting you may not need that much to protect your progre...
Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...
US market today: Pfizer posts strong first-quarter, sees boost from recent legal winsPfizer reported higher-than-expected sales and profit on Tuesday and said a patent extension for its Vyndamax heart drug and a recent favor...
Dr Reddy's gets nod to roll out generic oral semaglutide drug"The formulation was clinically evaluated in a head-to-head comparative study conducted in India, which established the non-inferiority to ...
New drugs could reach market sooner as govt halves trial review timelineThe Indian government is shaking up the pharmaceutical sector by slashing the review period for manufacturing applications for new drugs to...
Centre set to amend rules to simplify drug testing processThe Indian government is amending drug regulations to expedite the approval process for clinical trials and bioavailability/bioequivalence ...
Supreme Court orders Centre to respond to PIL on unethical clinical trials within four weeksThe Supreme Court has instructed the Centre to respond within four weeks to a PIL filed by Swasthya Adhikar Manch against unethical clinica...
Healthcare experts urge India to rewrite clinical trial rules to boost global market shareHealthcare experts suggest that India could increase its share in the global clinical trials market by learning from countries like China a...
India emerging as a top destination for clinical trials, says reportIndia's regulatory reforms since 2013 and the New Drugs and Clinical Trial Rules of 2019 have made it an attractive destination for clinica...
Healthcare NGO raises concerns over CovaxinA day before India begins the world’s largest Covid-19 vaccination drive, a group of healthcare-focused NGOs has sought clarifications from...
Government may soon allow import of untested drugs under trialThe ministry of health and family welfare is amending the New Drugs and Clinical Trials Rules 2019, enabling any government or private hosp...
Government notifies new rules for drugs and clinical trialsThe new rules will ensure patient safety, as they would be enlisted for trials with informed consent.
Easing clinical trial rules to compromise safety of subjects, say health activistsEthics committee, registered with DCGI according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting ...
With provision for jail term, clinical trial norms to get a shot in the armAs per the proposed rule, an independent expert committee will examine the reported adverse events and make recommendations to the DCGI.
- 'India emerging as pharma research hub'
Minister for Science & Technology Kapil Sibal believes India is emerging as a global pharma research hub.