FDA commissioner highlights efforts to improve expanded access program
The agency also launched in information website about Right to Try, which President Donald Trump signed into law in May.
The agency also launched in information website about Right to Try, which President Donald Trump signed into law in May.
FDA commissioner gives clues of agency's right-to-try strategy in Q&A session during chat with BIO President Jim Greenwood.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The law, which President Trump signed this week, allows patients to receive experimental drugs without FDA oversight.
The legislation, which has drawn criticism from researchers, patient advocates and industry, would enable patients to request experimental drugs while bypassing the FDA.
Although the Senate handily passed a proposal authorizing Right to Try in August, the House vote failed to get a two-thirds majority with a vote of 259 to 140.
The Senate approved the feel good legislation which was hotly debated at the MedCity CONVERGE conference this week.
Should unproven drugs be made available to terminally ill patients? Vice President Mike Pence looks to be preparing that discussion for the national stage, hosting "Right to Try" advocates at the White House.
The renewed interest in compassionate use — which first emerged as a national issue during the AIDS crisis of the 1980s — also has spurred pharmaceutical companies to ramp up “expanded access” programs.
A forum convened by patient advocates will serve as the launching event for the ICER Watch patient portal, which will track the movements of the Institute for Clinical and Economic Review, which last month released a report on the effectiveness of treatment options for multiple myeloma.