FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,039 codified at 21 C.F.R.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

Pfizer

AUGUST 15, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION. Anticonvulsant: carbamazepine, primidone, phenytoin.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

DECEMBER 13, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION . Antimycobacterials: rifampin. Herbal Products: St.

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. IMPORTANT SAFETY INFORMATION.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

NOVEMBER 23, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION. Antimycobacterials: rifampin. Herbal Products: St.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells. billion in 2022.

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Sales Manufacturing FDA Approval Life Science 98