Containment Cosmetics FDA Approval Regulation 
Advarra
JULY 26, 2022
Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.
Pharma in Brief
JANUARY 7, 2024
On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. The export regulations were later incorporated into the Food and Drug Regulations ( FDR ) in 2021.
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The Pharma Data
NOVEMBER 29, 2021
The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. The FDA, an agency within the U.S.
The Pharma Data
MARCH 15, 2022
This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Source link: [link] ov/.
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).
FDA Law Blog
APRIL 21, 2024
Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ).
FDA Law Blog
MARCH 13, 2024
156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).
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