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Food and Drug Administration (FDA) FDA Approval New Legislation

Womble Bond Dickinson

Florida Bans Cultivated Animal Cell Products

Womble Bond Dickinson on

In this blog, we have written a number of times on the topic of cultivated, i.e., lab grown meats. Last year, the FDA gave final regulatory approval for two different companies to sell their cultivated chicken in the United...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Bricker Graydon LLP

Ohio law prohibits COVID-19 vaccination mandates for public schools; Outlaws mandates of vaccines without “full” FDA approval and...

Bricker Graydon LLP on

On July 14, 2021, Governor Dewine signed House Bill (H.B.) 244 into law. The new law becomes effective 90 days after the governor’s signature. Under H.B. 244, public schools may not: ..Discriminate against an individual...more

Goodwin

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

Goodwin on

On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Hogan Lovells

New Legislation Increases Access to Medical Products for Military Applications

Hogan Lovells on

Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more

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