The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more
Providing further clarification to drug manufacturers about specific costs that can be charged for investigational drugs used in clinical and expanded access trials...more
• FDA has announced new quality metrics pilot programs that seek industry stakeholder perspective and feedback. • FDA’s voluntary pilot programs target companies submitting Type C and Pre-ANDA meeting requests, as well as...more
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more
On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. ...more
Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access...more