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Your search for ‘Hyman, Phelps, & McNamara’ returned 249 results

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  • Article

    Access To HPM's Free FDA Enforcement Webinar Now Available!

    Thanks to everyone who joined us today. We are excited that you were able to join us for our discussion of enforcement under the new FDA. We hope you enjoyed a lively conversation.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Sell-Out Crowd For HPM's Enforcement Webinar

    We have reached maximum capacity for this Thursday's webinar! We are excited by the large interest in this topic, and are eager to share our insights about the latest changes impacting...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
Article

Adios To Synthetic Colors In Food?

Our good friends Virginia and West Virginia have become the first states in the nation to restrict the availability of foods containing certain synthetic colors (or in FDA parlance, certain colors subject to certification)
United StatesFood, Drugs, Healthcare, Life Sciences
Hyman, Phelps, & McNamara
Hyman, Phelps, & McNamara
  • Article

    ACI's 42nd FDA Boot Camp – New York City Edition

    The American Conference Institute's ("ACI's") popular "FDA Boot Camp"—now in its 42nd iteration—is scheduled to take place...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Pharmacy Law And Licensing Highlights 2025

    As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The rules were implemented to enhance patient safety protections via revised drug handling, packaging...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    HPMers Slated To Speak At FDLI's Enforcement, Litigation And Compliance Conference

    The 2023 Food and Drug Law Institute's ("FDLI") Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman...
    United StatesCompliance
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    14th Asia Pacific Symposium On Cochlear Implant And Related Sciences Set To Convene In Seoul — Featuring HP&M's Dr. Philip Won

    The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    ACI's 3rd Annual Forum On Advanced Therapeutics

    The American Conference Institute's 3rd Annual Forum on Advanced Therapeutics is scheduled to take place from March 19-20, 2025, at the Seaport Hotel in Boston, MA.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    ACI's 23rd Advanced Summit On Life Sciences Patents

    Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institute's 23rd Advanced Summit on Life Sciences Patents...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    ACI's 21st Annual Paragraph IV Disputes

    The American Conference Institute's 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Don't Forget To Register For HPM's May 1 Webinar On Enforcement Under The New FDA!

    As a reminder, Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    ACI's 13th Annual Legal, Regulatory & Compliance Forum On Cosmetics & Personal Care Products

    The American Conference Institute's ("ACI") 13th Annual Legal, Regulatory & Compliance Forum on Cosmetics & Personal Care Products returns March 12-13, 2026...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Who You Gonna Email? Digital Health Question Busters!

    Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Another DOJ Self-Disclosure Policy – This Time For M&A Lawyers

    DOJ has issued another "voluntary disclosure" policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition.
    United StatesCorporate/Commercial Law
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    No ACNU Yet; Effective Date Delayed Again

    On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Federal District Court Vacates FDA's Laboratory Developed Tests Final Rule

    On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDA's Laboratory Developed Tests (LDT) Final Rule be vacated and set aside...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Bring Out Your Meds! To The Feds!

    With a nod to the immortal phrase, "Bring out your dead! Bring out your dead!" uttered by body collector Eric Idle, and to the Knights Who Say "Ni!," from the 1975 comedy romp, Monty Python and the Holy Grail...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Outlining The Legal Arguments Against FDA's Proposed Rule Regulating LDTs

    In a new publication in the Washington Legal Foundation's (WLF) Legal Backgrounder, we argue that FDA's recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Is Open To The Idea Of Possible Regulatory Flexibility For Cell And Gene Therapies On A Case-by-Case Basis…Where Appropriate

    Yesterday, FDA announced "Flexible Requirements for Cell and Gene Therapies to Advance Innovation."
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    ACI's 12th Annual Legal, Regulatory, And Compliance Forum On Cosmetics & Personal Care

    The American Conference Institute's 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara

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