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.
Pharma in Brief
JANUARY 7, 2024
Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).
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),
Pharmaceutical Technology
MARCH 30, 2023
Legislation and budget breakdown The budget proposes new legislative powers and extra funding for specific FDA projects: API CMOs named on labels: Drug labels would be required to name manufacturers of APIs. Senate and House subcommittees will hear testimony on 31 March and 10 April.
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.
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