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Joint Basis for FDA/HHS Marijuana Rescheduling …

WEBJoint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled. In August 2023 the Food and Drug Administration (“FDA”) and Health and …

Actived: 9 days ago

URL: https://www.thefdalawblog.com/2024/01/joint-basis-for-fda-hhs-marijuana-rescheduling-recommendation-unveiled/

Changes to Existing Medical Software Policies Resulting from …

WEBNearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by …

Category: Food Go Health

FDA Creates a New Advisory Committee for Genetic Metabolic …

WEBOn December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic …

Category: Health Go Health

Food and Drug Omnibus Reform Act of 2022

WEBEXECUTIVE SUMMARY. On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated …

Category: Food Go Health

New Prescription Drug Price Transparency Law in Virginia

WEBOn March 24, 2021, Virginia became the latest state to enact a prescription drug price transparency law. Similar to other state drug price transparency laws (see, for example, …

Category: Health Go Health

Corporate Liability from Employee Diversion: Costly on Many Fronts

WEBOn June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in …

Category: Health Go Health

While we know that the Food and Drug Administration’s …

WEBDecember 5, 2023 President Joseph R. Biden, Jr. The White House 1600 Pennsylvania Avenue, N.W. Washington, D.C. 20500 Dear Mr. President, Thank you for your …

Category: Health Go Health

THE FOOD AND DRUG ADMINISTRATION MODERNIZATION …

WEB2 Services (hereinafter FDA) to prepare a plan for implementing FDA’s statutory compliance in consultation with appropriate scientific and academic experts, health care professionals,

Category: Health Go Health

Be Still, My Beating Heart: FDA Announces Qualified Health Claims …

WEBChocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the …

Category: Health Go Health

Memo: Public Health Security and Bioterrorism Preparedness …

WEBHPM SUMMARY PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Pertinent Highlights of the Act Provides for a drug, …

Category: Health Go Health

Is The Skinny Label Back From the Dead

WEBSince the August 2021 decision in GSK v. Teva, the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny …

Category: Health Go Health

A Long Time Coming: DEA Regs Finally Authorize Schedule II …

WEBThe Final Rule. a. General Requirements. DEA’s final rule allows the partial filling of a prescription for a schedule II substance at the request of either the prescribing …

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FDA Publishes Draft Guidance on Voluntary Malfunction Summary …

WEBOn December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices.. Generally, FDA’s MDR …

Category: Medical Go Health

FDA End-of-Year Release of Warning Letters Impresses (or …

WEBPrimacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It’s why litigators concentrate on their …

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Ding Dong is the Skinny Label (Effectively) Dead

WEBTeva decision, the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted …

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Up, Up and But Not Away: DEA Raises Registration Fees

WEBDEA concluded that calculating fees using this methodology is “not reasonable” as required by the CSA as the disparity among registrant would be “too …

Category: Health Go Health

South Korea Aims to Establish Biohealth Industry as Strategic …

WEBSouth Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical …

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Research Institution Pays $3.9 million HIPAA Settlement for Breach

WEBBy David C. Gibbons & Jeffrey N. Wasserstein –. On March 16, 2016, the Feinstein Institute for Medical Research, located in Manhasset, New York, (“Feinstein”) …

Category: Medical Go Health