FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

FDA Approval 40

FDA Approval FDA Production Drugs 40

Broad Institute

FEBRUARY 8, 2024

Related news Scientific coalition developing surveillance system for detecting emerging pandemics in real-time While combing through the human genome in 2007, computational geneticist Pardis Sabeti made a discovery that would transform her research career. Finding participants for the study would be challenging too.

Research 81

Research Virus Hospitals Disease 81

The Pharma Data

NOVEMBER 15, 2020

However, doctors are continuing to prescribe the drugs “off-label” for kids with conditions like attention deficit hyperactivity disorder (ADHD), anxiety, depression and conduct disorders, the research found. SUNDAY, Nov. The medications don’t have the safety and effectiveness data needed, nor do they have U.S. .

FDA Approval 52

FDA Approval Doctors Treatment Therapies 52

FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” Plainly, the Government brief states “The decision below is incorrect. The Government’s brief puts a lot of faith in the existing regulatory system rather than the patent system.

Government 72

Government FDA FDA Approval Doctors 72

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. This has happened before with other drugs.

Clinical Trials 67

Clinical Trials Virus Vaccine DNA 67

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

Regulations 59

Regulations Production FDA FDA Approval 59