Remove 2001 Remove Packaging Remove Therapies Remove Treatment
article thumbnail

Where is the promise for plant-based medicines? Part 2: Psilocybin 

Drug Discovery World

This looks to be a significant milestone which will ideally propel other regulatory agencies forward in this field. For instance, though psilocybin remains illegal in Maryland, The Johns Hopkins Center for Psychedelic and Consciousness Research continues to explore innovative treatments using psilocybin and its potential for mental illnesses 3.

article thumbnail

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Member State, with orphan drugs or advanced therapy products’ requirements limited to the applicable patient population. citizens; 2.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. 2001) (no causation where medical personnel “had no alternative other than to use the. . .

article thumbnail

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. April 1, 2022) (the companion case to this ). at *3 (emphasis original). Hoffman-LaRoche, Inc. , 2d 806, 817 (5th Cir.