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

The Pharma Data

FEBRUARY 1, 2021

Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). CAMBRIDGE, Mass., 01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. Nasdaq: BIIB) today announced that the U.S. percent vs. 32.1

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. However, it is possible.

Marketing 52

Marketing FDA Approval Branding Production 52

The Pharma Data

AUGUST 5, 2020

The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.

Trials 52

Trials Medicine Production Containment 52

Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen).

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40