2024 Controlled Substances Labelling 
Pharmaceutical Technology
MARCH 30, 2023
Table 1: Medical product (drugs, devices, and diagnostics) safety budget, 2023 vs. 2024 Source: FDA; GlobalData © GlobalData Whether the proposal passes, and with what alterations, will depend on US Congress. This is made up of $2.1bn in direct funding and $2.4bn in user fees.
FDA Law Blog: Biosimilars
JANUARY 18, 2024
Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA.
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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. § Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. Patent Nos. sections 331(a) and 352. sections 331(a) and 352.(a)(l),
LifeProNow
MARCH 10, 2023
billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight.
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. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). By Larry K.
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. June 25, 2024. Epub 2018 May 14.
Pharma in Brief
JANUARY 7, 2024
On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. 01.014.13).
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