Drug Discovery World

DECEMBER 6, 2022

The MPE report presents clinical trial analytics, looking at the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020. The situation has worsened with the increasing number of physicians and nurses leaving some CEE countries to work in Western Europe (the “brain drain”) . The findings .

Clinical Trials 130

Clinical Trials Trials Nurses International 130

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

FDA 40

FDA Regulations Production Packaging 40

The Pharma Data

OCTOBER 18, 2020

Richner received a Master of Public Health in Health Policy and Administration and a Bachelor of Science in Nursing from the University of Michigan in Ann Arbor, Michigan. develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke.

Compliance 52

Compliance Production Marketing Government 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ).

Government 59

Government Regulations FDA Nurses 59

Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. Buckman Co. 201.326(a)(1).

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

FDA 64

FDA Nurses Production Regulations 64