Containment Cosmetics Licensing Regulation 
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
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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).
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Advarra
JULY 19, 2022
The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3, The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,
FDA Law Blog
FEBRUARY 29, 2024
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. From there, the PTO notes that a PTE “determination is made based on the representations contained in the PTE application,” and that “35 U.S.C. § Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.
The Pharma Data
NOVEMBER 26, 2020
We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. The record results achieved on November 25, 2020 were followed up by another very strong showing on Thanksgiving Day (November 26, 2020).
FDA Law Blog
NOVEMBER 22, 2021
This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). Please see our previous blog postings on various software regulatory developments ( here, here, and here ). corrections and removals).
Pfizer
AUGUST 15, 2022
One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. FDA Emergency Use Authorization Statement. anti-infectives).
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