XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act.

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FDA Approval Containment Drugs Pharmacy 98

The Pharma Data

NOVEMBER 4, 2020

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

Licensing 40

Licensing Licensing Dermatology Production 40

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.

Development 161

Development Production Immune Response Licensing 161

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is your advice for approaching the regulatory strategy?

Packaging 52

Packaging Packaging Drugs Containment 52

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 company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment.

Life Science 52

Life Science Production Cosmetics Manufacturing 52

FDA Law Blog

NOVEMBER 1, 2023

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 ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

Pfizer

DECEMBER 13, 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. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110