With almost no fanfare, President Obama signed the FDA Safety and Innovation Act (SIA) into law earlier this month. The popular and legal media coverage of the bill leading up to its enactment seemed to focus on the reauthorization of user fees for prescription drugs and medical devices and the creation of new user fees for generic drugs and biosimilars. As usual, the user fees are accompanied by performance goals for the FDA’s review of the related applications. But the SIA also contains a host of other provisions relating primarily to drugs and medical devices.With respect to medical devices, § 601 of the SIA precludes the FDA from refusing to approve an Investigational Device Exemption simply because it determines that the proposed study alone will not support an approval to market the device. Section 602 refines the “least burdensome” provisions to specify that FDA can only request the “minimum required information” to support clearance or approval to market a device. Section 603 requires the FDA to document the rationale for “significant decisions” in connection with IDEs, 510(k)s, and PMAs.Section 604 requires FDA to withdraw a draft guidance on when a modification to a device requires a new 510(k) and to… Read full this story
- Allergy risk on Pfizer jab: Day before FDA meet to give green light to vaccine UK regulators warn people with 'significant' food and medicine allergies NOT to take it after two health workers suffer 'anaphylactic reaction'
- FDA panel votes to give emergency approval to Pfizer's coronavirus vaccine - but the shot won't ship to Americans until the agency signs off and a final verdict could take DAYS
- The state of business and IT innovation
- FDA issues emergency use authorization for Pfizer/BioNTech Covid-19 vaccine
- FDA faces coronavirus vaccine approval while mired in political controversy
- FDA Approves Pfizer’s Coronavirus Vaccine
- Donald Trump is 'livid' that America is not the first country to approve the Pfizer jab amid frustration that the FDA is not moving faster to give the vaccine the go-ahead
- America records ONE MILLION new COVID cases in just five days as Dr Birx hits out at governors who refuse to reintroduce the lockdowns that curbed the summer spread
- Head of U.S. vaccine program predicts the FDA panel WILL grant emergency approval to COVID-19 vaccine when it meets Thursday as Health secretary says he is 'worried' people won't act safely at Christmas
- Citibank Launches Innovative Digital Value Proposition Citi Plus
The FDA Safety and Innovation Act: Much More Than Just User Fees have 396 words, post on www.natlawreview.com at July 21, 2012. This is cached page on wBlogs. If you want remove this page, please contact us.