STAT
NOVEMBER 11, 2022
Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy.
pharmaphorum
OCTOBER 14, 2020
It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration. The company added another alternative, Xywav (calcium, magnesium, potassium, and sodium oxybates) earlier this year although these drugs lack the cataplexy use on their label.
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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. Labeling Requirements DASCA also added a labeling requirement in the CSA to identify products containing anabolic steroids.
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.
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. sections 331(a) and 352. sections 331(a) and 352.(a)(l),
Pharma in Brief
NOVEMBER 29, 2020
of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. Controlled substances, biologics, and certain injectable drugs are not eligible for importation. Interim Order Context.
LifeProNow
MARCH 10, 2023
million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. Funding will support broader development of opioid overdose reversal treatments and treatments for substance use disorders and enhance regulatory oversight, expand compliance, enforcement and laboratory support.
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