India’s draft e-pharmacy rules put in place a series of checks and balances to ensure that only genuine e-pharmacies engage in online sales of medicines. Registration and strict record keeping requirements, among other aspects, are mandated under the rules, though it may take a “leap of faith” when it comes to security of patient data, some experts say.
India’s draft e-pharmacy rules permit only registered e-pharmacies to conduct business in the country and specify requirements to ensure that records of drugs dispensed and patient details are maintained appropriately and safely.
The rules require all e-pharmacies to be registered with the Central Licensing Authority – the Drugs Controller General of India...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
