Pfizer

DECEMBER 20, 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 69

Drugs Licensing Licensing Containment 69

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. There is also substantial interest, from major industry players, in the Company’s proprietary Tauri-Gum product line.”. . ABOUT TAURIGA SCIENCES INC. .

Life Science 52

Life Science Production Cosmetics Manufacturing 52

Advarra

JULY 19, 2022

Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? At what point does the drug substance become a drug product? The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3, Q: What is the definition of a drug?

Packaging 52

Packaging Packaging Drugs Containment 52

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This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17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). Summaries of the impact of the 21st Century Cures Acts on software and the definition of a medical device are available here, here, here, and here.

Containment 52

Containment Production Cosmetics Development 52

Pfizer

NOVEMBER 23, 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., Our Commitment to Access. AUTHORIZED USE.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

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. Herbal Products: St. FDA Emergency Use Authorization Statement. 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

Production 52

Production Sales Drugs Cosmetics 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

FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. 21 U.S.C. § 802(16)(B). chemotherapy-induced), pain, and post-traumatic stress disorder.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69