60 matches.
- PublicationsSolving the EDDO Guidance Puzzle1 minute read
- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- EventsAMCP 2025: Understanding 340B Stakeholder Perspectives, Litigation Trends, and Reform Prospects2 minute read
- Media CoverageMegan Robertson Quoted in “5 Tips for Building a Predetermined Change Control Plan”3 minute read
- PublicationsUS Courts Health Disaster as It Drops the Ball on Flu Preparedness2 minute read
- PublicationsACIP’s Upcoming Meningococcal Recommendations: Added Complexity, Reduced Choice1 minute read
- Media CoverageRichard Hughes Quoted in “CDC Plans Study on Vaccines and Autism Despite Research Showing No Link”4 minute read
- Media CoverageRichard Hughes Quoted in “Trump’s FDA Nominee Grilled on Vaccine Meeting, Agency Staffing”8 minute read
- Media CoverageRichard Hughes Quoted in “Kennedy's Early Warning Signs on Vaccine Policy”4 minute read
- PublicationsExpanding Vaccination Provider Types and Administration Sites Can Increase Vaccination Uptake: A Systematic Literature Review of the Evidence in Non-United States Geographies2 minute read
- Media CoverageRichard Hughes Quoted in “F.D.A. Cancels Meeting of Vaccine Experts Scheduled to Advise on Flu Shots”2 minute read
- EventsFDLI Enforcement, Litigation, and Compliance ConferenceDecember 10-11, 20241 minute read
- PublicationsMedicare Coverage of Antiobesity Medicines1 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Regulatory, Industry, and Legal Perspectives on the Future of the DSCSA3 minute read
- Media CoverageRichard Hughes Quoted in “DOJ Asks SCOTUS to Reverse Braidwood Ruling, Uphold ACA’s Preventative Mandate”3 minute read
- Media CoverageChristopher Smith Quoted in “HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA”5 minute read
- EventsHDA 2024 Traceability Seminar: Legal Perspectives for DSCSA Compliance Teams1 minute read
- EventsNACDS Total Store Expo: The DSCSA and Chain Drug Stores - Recent Developments and the Future1 minute read
- EventsNational Association of Chain Drug Stores Total Store Expo Pharmacy Compliance Roundtable1 minute read
- PublicationsFTC Releases Controversial Interim Staff Report on PBMs’ Purported Impact on Drug Prices3 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
- BlogsFDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners13 minute read
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs- Media CoverageRichard Hughes Quoted in “Feds' 5th Circ. Win on Preventive Care May Imperil ACA”3 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Mandate Battle Shifts After Appeals Court Speaks”3 minute read
- Media CoverageRichard Hughes Quoted in “‘A Mixed Bag’: Fifth Circuit Rules on ACA Preventive Services Legal Case”3 minute read
- Media CoverageRichard Hughes Quoted in “Appeals Court Finds 'Obamacare' Pillar Unconstitutional in Suit Over HIV-Prevention Drug”3 minute read
- Media CoverageRichard Hughes Quoted in “Court Upholds ACA’s Free Preventive Services Mandate”3 minute read
- Media CoverageRichard Hughes Quoted in “News Briefs: Court Upholds ACA Preventive Services Coverage Mandate, for Now”2 minute read
- Media CoverageRichard Hughes Quoted in “Fifth Circuit Maintains ACA Preventive Mandate; but Remands Vaccine, Birth Control”1 minute read
FDA Releases Laboratory-Developed Tests Final Rule- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- Events340B Coalition Winter Conference 2024: Contract Pharmacy Deeper Dive1 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved”2 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Drug Supply Chain Security Act Changes and Implications for Dispensers2 minute read
- Media CoverageRichard Hughes Quoted in “RSV Vaccines Aren’t Covered by Medicare for These Vulnerable Groups”2 minute read
- Media CoverageRichard Hughes Quoted in “Opinion: It Shouldn’t Be So Hard for Older Adults to Receive the RSV Vaccine”2 minute read
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Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 minute read
- PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
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Direct Access Laboratory Testing: Reimbursement & Compliance
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- EventsFrom Roe to Dobbs: Reviewing Changes to Reproductive Health Care Operations and Forecasting What’s Next2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- EventsNACDS: Pharmacy Compliance with the Drug Supply Chain and Security ActOctober 12, 20221 minute read
- Media CoverageRichard Hughes, Kala Shankle Featured in “Viewpoint: Pharmacists Need Standard Pathway to Bill for Paxlovid”2 minute read
- PublicationsPharmacists Can Now Prescribe Paxlovid, but Barriers Persist4 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
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Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- PublicationsFDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure18 minute read
- EventsAHLA Academic Medical Centers and Teaching Hospitals Law Institute 2022: Precision Medicine Studies—A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and ResearchFebruary 2, 20222 minute read
Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 minute read