Cosmetics Licensing Regulation Sales 
pharmaphorum
JULY 16, 2021
French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront. . It is due to readout in the first half of next year.
FDA Law Blog
AUGUST 17, 2022
Where a consumer spends additional money to receive an OTC hearing aid from a licensed professional, the consumer protections required to be provided by the licensed professional apply; otherwise, those consumer protections may not, as state consumer protections typically are required only of licensees.
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XTalks
FEBRUARY 8, 2021
While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.
FDA Law Blog
FEBRUARY 29, 2024
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.
The Pharma Data
NOVEMBER 26, 2020
in Daily E-Commerce Sales and recorded 103 individual E-Commerce Order Transactions (average order size: $92.37). 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. On Wednesday, November 25, 2020, the Company generated $9,514.49
FDA Law Blog
JUNE 21, 2022
For those unfamiliar with the hearing aid industry, the industry faces regulations on all fronts: FDA regulates the devices while states regulate their distribution and impose conditions of sale via their licensing authority over “hearing health professionals” including audiologists or hearing aid dispensers.
FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
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