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Food and Drug Administration (FDA) › Notice and Comment

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

Foley Hoag LLP - Cannabis and the Law on

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Holland & Knight LLP

CMS Proposes Transitional Coverage for Emerging Technologies

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more

Venable LLP

New Federal Law Aims to Identify and Prevent or Mitigate Organizational Conflicts of Interest in Federal Contracting

Venable LLP on

In the midst of the year-end legislative push, Congress last week passed S. 3905, the "Preventing Organizational Conflicts of Interest in Federal Acquisition Act." This "good government" law requires the Federal Acquisition...more

Goodwin

FDA Schedules Public Meeting and Request for Comments on Biosimilar User Fee Act

Goodwin on

Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

Health Care Compliance Association (HCCA) on

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Foley & Lardner LLP

EUAs for LDTs no Longer Required, but at the Expense of PREP Act Immunity

Foley & Lardner LLP on

On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more

Genova Burns LLC

The ABC's of CBD Regulation

Genova Burns LLC on

“Isn’t hemp the same thing as cannabis (marijuana)?” The difference between cannabis and hemp stem from their most widely studied and commonly known chemical compounds: tetrahydrocannabinol (“THC”) and cannabidiol (“CBD”)....more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

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