US Supreme Court’s EPA Ruling Expected To Have Limited Impact On FDA Regulations
Executive Summary
Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.
You may also be interested in...
Supreme Court Rules Narrowly Against Medicare Payments Cuts To 340B Hospitals
The decision doesn’t directly impact manufacturers or the 340B discounts they are required to provide – and does not address the potentially much broader regulatory issue of whether the Supreme Court’s so-called Chevron doctrine should be changed.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.