The Pharma Data

MAY 13, 2021

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Production 52

Production Treatment Vaccine Therapies 52

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JULY 13, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

FDA 40

FDA Packaging Laboratories Testimonials 40

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

Testimonials 59

Testimonials Doctors Production Laboratories 59