Leaders at FDA’s drug center appear more closely aligned with the OTC industry than with medical professionals’ groups on consumer access to innovative switches. CDER Director Woodcock says the clinical community has resisted switches – and been proven wrong – before.
FDA will prioritize consumers’ direct access to more nonprescription pharmaceuticals through conditions of safe use over requiring intervention by pharmacists, agency officials say.
Drug center officials’ comments at the Consumer Healthcare Products Association’s Regulatory & Scientific Conference May 10-11 show FDA is aligned...
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
