Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults.

Trials 52

Trials Medicine Production Containment 52

Druggist

MARCH 25, 2021

Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. Tablet’s core.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. SOUTH SAN FRANCISCO, Calif.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40