16 matches.
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown
- Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- PublicationsA Patchwork in Need of Permanent Repair: The U.S. Framework for Recommending and Covering Preventive Care2 minute read
- Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- PublicationsCOVID-19 Vaccine Prices Are Going Up. It Shouldn’t Be Our Focus.2 minute read
- PublicationsCOVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious ObjectionsAugust 11, 202210 minute read
- PublicationsCOVID-19 Vaccine and Monoclonal Coverage: A Focus of the 2023 Medicare Physician Fee Schedule Proposed RuleAugust 1, 202210 minute read
- Media CoverageRichard Hughes’ Article on Immunization Access Cited in “A Twenty-First Century 'Vaccines for Children' Program”July 12, 20223 minute read
- EventsBIO International Convention: Vaccine Innovation and the Future of Life-Course ImmunizationJune 14, 20222 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to FruitionMay 20, 20226 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- EventsMulti-Cancer Early Detection Through Novel Blood Tests: Developing Appropriate Regulatory and Reimbursement Pathways1 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management5 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read