Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Products 21 CFR Parts 3 a...
UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.
FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.
FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.
FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.
FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs Eliquis with a higher ...
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.
