JD Supra26d
FDA announces public meeting on pediatric exclusivity and drug development
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and ...
The American Journal of Managed Care8d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
MedPage Today27d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
In light of this, the OIG examined the FDA's decision-making process in a sample of 24 accelerated ... In addition, some meetings with Biogen about aducanumab appeared to be missing from the ...
Hosted on MSN28d
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
Also, concerns about the efficacy of both drugs was brought up by both FDA scientist and advisory committee members. OIG also noted that in the case of aducanumab, Biogen's meetings with the ...
Yahoo Finance12d
Karolinska Development’s portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
Positive outcomes from scientific advice meetings with the FDA and the EMA, were followed by a Simultaneous National Scientific Advice, SNSA, including five key national EU authorities ...
Food Safety News8d
Legislators want the FDA to be able to test samples from feed lots during outbreaks
Two U.S. legislators have introduced a bill that would give the FDA the ability to collect microbial samples at feed lots during foodborne illness ...
Taiwan News12d
Karolinska Development’s portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Dilafor has successfully completed regulatory meetings with the U.S. Food and Drug Administration, FDA, ...
manilatimes13d
Karolinska Development's portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Dilafor has successfully completed regulatory meetings with the U.S. Food and Drug Administration, FDA, ...