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

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  • Article

    Skinny-Label Lives To See Another Day

    Further talks of the Skinny Label's demise may be premature, as demonstrated by a new decision from the District Court for the District of Columbia upholding FDA's interpretation of the "same labeling" provisions of the Hatch-Waxman Amendments.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Where Does Rare Disease And Patient-Focus Fall Into Commissioner Makary's Priorities & The MAHA Platform For FDA? A New Ultrarare Approval Pathway & More

    There is much change happening at FDA. In the wake of the April 1st reduction in force, there has been a great deal of uncertainty about what the impacts will be.
    United StatesFood, Drugs, Healthcare, Life Sciences
Hyman, Phelps, & McNamara
Hyman, Phelps, & McNamara
  • Article

    AI May Make Your Device More Efficient, But Be Prepared To Spend More Time On Design Documentation

    In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Would Like To Join You In The Sandbox When Developing AI Enabled Devices

    In the past three months, FDA has released two guidance documents related to artificial intelligence (AI) enabled medical devices: (1) a final guidance...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Proposed LDT Rule Raises Many Questions But Provides Few Answers

    As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Guidance Outlines A Framework For The Evaluation Of Long-Term Neurodevelopmental Safety Studies In Neonatal Product Development

    The neonatal period is a unique and complex period of rapid growth and development throughout the body, thus creating unique and complex challenges...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    The Great RIF(T): One FDA Division's Destruction And What It Could Mean For Generic Drugs

    The FDA Reduction-in-Force (Termination)—or "RIF(T)"—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF'd.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    When Is An Approval Not An Approval? Before 1962.

    Priority Review Vouchers (PRV) are incredibly valuable—several have sold for hundreds of millions of dollars.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Prescribing Red Flags And Suspicious Controlled Substance Orders: Current Cautionary Tales

    Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Recalls: They Aren't Over 'Til FDA Says So, But Who Knows When That Will Be

    On December 8, 2025, the Government Accountability Office (GAO) sent a report to Senators Richard Durbin and Richard Blumenthal in response to the Senators' request for GAO to review...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    What To Do When You Receive A DEA Order To Show Cause

    We published a version of this post several years back (see here), but recent updates to the law and trends in DEA enforcement merit a refresher.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    "If You've Got Legitimate Suspenders, Don't Have An Unconstitutional Belt:" Federalist Society Panel's Take On Jarkesy And The Preserve Access To Affordable Generics And Biosimilars Act

    On August 30, 2024, we posted on what was then the most recent version of S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.
    United StatesIntellectual Property
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Surely You Must Be Kidding, PTO?!? "No, And Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World Of Recent Patent Term Extension Decisions (PART 1)

    It's been a while since we last blogged on Patent Term Extension ("PTE") issues of interest. And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman...
    United StatesIntellectual Property
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA's New Draft Guidance On 510(k) Implant Devices: What You Need To Know

    As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Joint Basis For FDA/HHS Marijuana Rescheduling Recommendation Unveiled

    In August 2023 the Food and Drug Administration ("FDA") and Health and Human Services ("HHS") recommended that the Drug Enforcement Administration...
    United StatesCannabis & Hemp
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Issues Long-Awaited QMSR Final Rule

    More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA-Approved Labeling: Is Enough Enough?

    I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Inspections: Lesson 1 – Interviewing Employees

    This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these "lessons" will illustrate...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Onshoring Drug Manufacturing: Insights From FDA's PreCheck Initiative And Public Meeting

    By increasing regulatory predictability and reducing delays, PreCheck aims to spur U.S. investment
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Why, Who, When, Where And More: New Draft Guidance On Notifying FDA About Discontinuance Or Interruption In Manufacturing

    On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Showing 201–220 of 249 results

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