FDA Law Blog: Biosimilars

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter. That’s important, because PTE applications for U.S. Patent Nos.

Labelling 59

Labelling Controlled Substances 59

FDA Law Blog: Biosimilars

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Clearly, OPDP thinks differently.

Labelling 52

Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

The Thyroid Pharmacist

NOVEMBER 15, 2024

Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use). Ozempic’s label warns, “In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. Published 2022 Feb 17. 2022;27(4):1351.

Diabetes 75

Diabetes Immunization Immunity Compounding 75

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

Controlled Substances 59

Controlled Substances Packaging Labelling Hospitals 59

FDA Law Blog: Biosimilars

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Statement from President Biden on Marijuana Reform, White House (Oct.

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95