Topic
FDA Approval
200 published works
Inside EU Life Sciences
Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route
By Grant Castle, Marie Doyle-Rossi
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows…
Big Molecule Watch
FDA Approves Celltrion’s YUFLYMA (adalimumab-aaty), a Biosimilar to HUMIRA
Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile…
Drug & Device Law
Mifepristone Manufacturer Wins First Round in West Virginia
By Bexis
Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom…
Religion Clause
5th Circuit Hears Arguments on FDA Approval of Abortion Drug
Yesterday the U.S. 5th Circuit Court of Appeals heard oral arguments (audio of full arguments) in Alliance for Hippocratic Medicine v. Food & Drug Administration. In the case, a Texas…
Health Care and Life Sciences
The Legal Battle Over Mifepristone
By Delia A. Deschaine, Erin Sutton, Spreeha Choudhury
During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and…
Health Care and Life Sciences
Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway
By Dominick DiSabatino, Audrey Mercer
On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved…
Drug & Device Law
This Is Why FDA Is Not a Black Box
A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval. …
Gender and the Law Prof Blog
Transcript of Abortion Pill Hearing Released
By Jamie Abrams
NPR has posted the full transcript of the Texas hearing Judge Matthew Kacsmaryk held last Wednesday in the Alliance for Hippocratic Medicine v. FDA case challenging the agency's 2000 approval…
Religion Clause
Transcript of Hearing Released in Challenge to FDA Approval of Mifepristone
On March 15, Judge Matthew Kacsmaryk in the federal district court in the Northern District of Texas held a hearing on the preliminary injunction motion in the widely-watched case of Alliance…
Personalized Medicine Bulletin
Personalized Medicine at FDA: The Scope & Significance of Progress in 2022
The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the…