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

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  • Article

    FDA Moves Beyond COVID-19, But Impacts On COVID-19 Era Clinical Trials Remain

    On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Medical Device Notification Warns Of Continued Data Integrity Concerns

    Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
Article

Regulatory Due Diligence Becomes More Critical In A "Hot" Year For Deals In The FDA Space

As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts...
United StatesFood, Drugs, Healthcare, Life Sciences
Hyman, Phelps, & McNamara
Hyman, Phelps, & McNamara
  • Article

    We Will Clear You: DEA's National Prescription Drug Take Back Day

    Were the Drug Enforcement Administration ("DEA") a rock band, it might promote the upcoming National Prescription Drug Take Back Day by setting the lyrics above to a catchy tune.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Senate Passes Revised Version Of The BIOSECURE Act

    On October 9, 2025, the U.S. Senate voted in favor of including a revised version of the BIOSECURE Act as an amendment to the National Defense Authorization Act (NDAA).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    The Sun Has Started To Set On The Rare Pediatric Disease Priority Review Voucher Program – But It Can Still Be Saved

    The Winter Solstice, signifying the shortest day of the year, was Saturday, December 21. Although the earliest sunset of the year was actually in early December...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Calling VC Firms: FDA Wants To Work With You

    FDA wants to capitalize on the talent of venture capital (VC) firms that are developing innovative solutions that can be applied to FDA's public health mission. On December 17, 2025...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Companies Shipping Chemicals: "Know The One You're Dancing With"

    Drug Enforcement Administration ("DEA") civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA's Proposal To Remove Oral Phenylephrine From The OTC Monograph Isn't A Surprise But What Is Left "Over-the-Counter"?

    On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA And The Device Industry: Friends Or Foes?

    "An open foe may prove a curse, but a pretended friend is worse." When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    How Many Hours Are Really In A Day?

    We recently blogged on FDA's draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    MAHA, Nutrition, And The FDA

    Among the more interesting developments in the recent election was the emergency of Robert Kennedy as a prominent figure in the MAGA movement...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    More On The Impact Of The FDA RIFs: How Information Disclosure Will Start FOIA-lling Behind

    The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Stop The Presses! DEA And DOJ Fine EBay For Not Reporting Sales Of Tableting And Pill Press Machines

    Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Where Have All The Good Guidance Gone?

    While this author needs no excuse to listen to Van Halen, one surprising source of inspiration came while reviewing the body of guidance documents issued by CDRH in the last year.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    CPSC Decision Highlights Some Don'ts Of Agency Rulemaking

    Every parent is familiar with the parade of horrors that accompany household items as mundane as window coverings.
    United StatesConsumer Protection
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Even In "Unprecedented" Times, There Is Precedent

    The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    It's A Bird, It's A Plane, It's Operation Stork Speed

    On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Knock Knock. Who's There? (Or Quién Es? Or Qui Est-ce? Or Wer Ist Es?) Surprise, It's FDA!

    On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Here's Looking At You, OTC Drugs: FDA Requests Information To Plan For Public Meeting On Increasing Access To Nonprescription Drugs And Issues New MaPP On OTC Switches And Generics

    As previewed by former CDER Director Tidmarsh at the Consumer Healthcare Products Association meeting in September, FDA announced last week its intent to schedule a public meeting...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Showing 41–60 of 249 results

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