Pharma in Brief
DECEMBER 3, 2023
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).
The Pharma Data
NOVEMBER 23, 2020
On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
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Worldwide Clinical Trials
FEBRUARY 21, 2024
Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. Here are a few of our lessons learned: 1. Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations.
XTalks
JUNE 5, 2023
Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). The approved drugs contain the base form of semaglutide. Instead, they may contain compounded semaglutide in salt forms, which could pose health risks.
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Co-Authors: Jenny Fielder.
FDA Law Blog
JULY 18, 2023
Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). That leaves 60% that manufacture at least one application product. The PHE also had a dramatic effect on import alerts.
Pharma in Brief
APRIL 13, 2021
The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.
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