Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Starting in 2007, a human trial in Ecuador and Peru found that this drug duo reduced HIV incidence by 44 percent among men who have sex with men; adherence issues likely prevented full protection. This has happened before with other drugs.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68

Drug & Device Law

JULY 31, 2023

2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.” Buhimschi , 2007 WL 2902896, at *16 (E.D. 28, 2007), aff’d , 396 F. Henry , 2007 WL 2743097, at *2 (W.D.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

FDA 69

FDA Production Trials Government 69