FDA Law Blog
MARCH 24, 2024
By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).
FDA Law Blog
NOVEMBER 15, 2022
Claud is a 15-year veteran of the Department of Justice, where most recently he was an Assistant Director of the Consumer Protection Branch overseeing the Corporate Compliance and Policy Unit. He is a frequent public speaker on matters of government enforcement strategies under the FDCA as well as corporate compliance best practices.
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XTalks
JUNE 5, 2023
During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. mg and 2.4 mg doses of Wegovy.
FDA Law Blog
FEBRUARY 12, 2023
Despite the apparent green light, it will be a while before we see Canadian drugs on our pharmacy shelves. Plaintiffs Other Alleged Harms Must Also Fail The judge next discussed plaintiffs’ allegations of past and present “compliance costs.” The final rule does not itself permit any drugs to be imported.
The Pharma Data
SEPTEMBER 11, 2020
This is due to these companies violating the Federal Food, Drug and Cosmetic Act which was passed in 1938 to give the FDA authority to oversee the safety of drugs. . The first wave of the opioid crisis began in the 1990s with the over-prescription of opioids from doctors and pharmacies.
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