FDA Law Blog: Biosimilars
AUGUST 4, 2023
Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed. By Larry K. 50,036 (Aug.
Pharmaceutical Technology
MARCH 30, 2023
The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. At present, the FDA can only force recalls for controlled substances and biologics, and relies on voluntary recalls by pharma companies for other drugs.
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LifeProNow
MARCH 10, 2023
March 09, 2023: “The U.S. The request includes an increase of $372 million in budget authority — or 10% above the FY 2023 Enacted Level — and a $150 million increase in user fees. 1, 2023, through Sept. Food and Drug Administration announced it is requesting $7.2 The FY 2024 request, which covers the period from Oct.
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. By Larry K.
The Happy PharmD
APRIL 26, 2023
Dexamethasone oral solution is not a narcotic or controlled substance. In February 2023 she had her next to last refill of the prescription filled. At the beginning of March 2023, I stopped by the pharmacy and asked for the last refill of the Dexamethasone oral solution. This one baffled me.
FDA Law Blog: Biosimilars
AUGUST 16, 2023
And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.
FDA Law Blog: Biosimilars
DECEMBER 14, 2023
The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).
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