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Florida approved to import Canadian prescription drugs

Pharma in Brief

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).

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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog: Biosimilars

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.

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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace

FDA Law Blog: Biosimilars

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),

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

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.

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Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. This is particularly important for sensitive medications such as controlled substances, which can be at a higher risk for counterfeiting and diversion.

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Blood Sugar, Hashimoto’s, Ozempic, Metformin and Berberine

The Thyroid Pharmacist

While vitamin B9 can be found naturally in foods in the form of folate, it can also be found in the form of folic acid, a manufactured and synthetic version of folate that is present in most bargain-priced multivitamins, as well as often added to processed foods. GLP-1 drugs also carry an increased risk for thyroid tumors, including cancer.