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

DECEMBER 17, 2020

TLC’s Ampholipad (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome ® in all three forms, proving its sameness as the originator. About TLC. Cautionary Note on Forward-Looking Statements. Source link.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

AUGUST 5, 2020

Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. J Neurol Sci. 2003;206(2):165–71.

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). A box of Cerelle or Cerazette pills comes with three blister blisters, each of which contains 28 mini-pills (note you may be prescribed just one blister = 28 pills). Both pills are taken in the same way.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Quitting smoking is an arduous, exhausting process. However, it is possible.

Marketing 52

Marketing FDA Approval Branding Production 52

FDA Law Blog

JANUARY 23, 2023

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. percent vs. 32.1 Available at: [link] Accessed: January 2021. 3 Zhao Y, et al. Source: Biogen.

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FDA Approval Bioequivalency Clinical Trials Clinical Trials 40