Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must be part of a 510(k)...
Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.
PhRMA gives FDA specific comments and edits on the International Council for Harmonization M11 protocol. Template, and technical specification.
The Centers for Medicare & Medicaid Services says it is not reconsidering its national coverage determination that restricts Medicare coverage on Alzh...
University of Pennsylvania researchers call on FDA to act more quickly when accelerated approval cancer drugs fail confirmatory tests to cut the time ...
FDA approves a BLA from Sanofis Bioverativ Therapeutics unit for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate in...
A JAMA study that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the drug does not reduce ...
FDA adds a new case study to its Examples of Medical Device Misconnections Web page.
