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Prescription Drugs Animal Drugs

Alston & Bird

Health Care Week in Review: Senate Democrats Released Draft Legislation to Prevent Labor and Delivery Unit Closures; CMS Announced...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Alston & Bird on

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Quarles & Brady LLP

DEA Issues New Regulation Formalizing Black Bag Exception for Veterinarians

Quarles & Brady LLP on

The Drug Enforcement Administration (DEA) recently issued a new regulation codifying provisions of the Veterinary Medicine Mobility Act of 2014 (VMMA). The VMMA, which was signed into law in 2014, allows a veterinarian to...more

Alston & Bird

Health Care Week in Review: House E&C Committee Held Mark-Up of 44 Bills, Biden Administration Announced Actions to Lower...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Quarles & Brady LLP

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

Quarles & Brady LLP on

The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more

Hogan Lovells

Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations

Hogan Lovells on

On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

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