Topic
FDA Approval
198 published works
Cannabis
California Legalizes Prescription Cannabidiol (Epidiolex)
At the end of June, we wrote about the FDA’s approval of GW Pharmaceutical’s drug Epidiolex (containing cannabidiol), an oral solution for treatment of seizures. On July 9, 2018, California…
Biosimilars Law Bulletin
U.S. FDA Approves First Biosimilar to Neulasta
Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was developed by Amgen and first approved in the U.S. and Europe in 2002. …
Food, Drug & Agriculture
Cheers to 80 Years: Celebrating the Anniversary of the Federal Food, Drug, and Cosmetic Act
By Ebunola Aniyikaiye, Lauren A. Farruggia, Megan Robertson
Eighty years ago today, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). In recognition of this anniversary, EBG reviews how the FD&C Act came to be,…
BioLoquitur
Good ANDA Submission Practices: Summary of Draft Guidance
By Parithosh K. Tungaturthi, Ph.D.
The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018.…
Napoli Shkolnik Blog
What Is the FDA Approval Process?
Before a prescription drug can be sold in the United States, it must go through a rigorous approval process managed by the U.S. Food and Drug Administration (FDA). The point…
The IP Law Blog
U.S. Supreme Court Allows Early Notice For Biosimilars
In SANDOZ INC. v. AMGEN INC. et al., the United States Supreme Court in a unanimous opinion ruled that biosimilar makers can give their required 180-day statutory notice of sales…
Biosimilars Law Bulletin
FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Amgen’s Epogen®/Procrit® (epoetin alfa)
Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s Epogen®/Procrit® for approval across all indications after a public meeting held on…
The Faculty Lounge
“Right to Try” Legislation
I blogged last week about the website Science Based Medicine, where you will find unfailingly interesting articles about the intersection of science and medical practice. I now want to recommend…
Focus on Regulation
New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act
The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA). Amendments to Regulations on Citizen Petitions, Petitions…
The Right Coast
FDA approves generic version of Viagra | Fox News
Good news for frugal guys with erection troubles: America will soon be up to its eyeballs in generic Viagra. CBS News reports the FDA approved the first generic version of…