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FDA approval normally follows a formal application supported by adequate evidence for a defined product, dose, route, patient population, manufacturing process, labeling, effectiveness, and safety profile
A Phase 2 trial (NCT01311518) was designed to test RGN-352 in ~75 heart attack patients, but was placed on FDA clinical hold in 2011 due to manufacturing (GMP) compliance issues at the contract site not safety concerns with the drug itself
Third-party results carry more weight than self-reported manufacturer testing
Despite its evocative name, its precise mechanism remains incompletely understood, which is exactly what makes it an enduring subject of experimental investigation into sleep, stress and neuroprotection
It often means pain plus bowel shifts, without the serious tissue damage seen with IBD
Many thanks to my brilliant co-authors for making this possible: Yasmeen Abdel Bari, Katharine Lynch-Kelly, Danish Hafeez, Livia Asan, Mark J Edwards, Dr Gertrude (Trudi) Seneviratne OBE (she/her), Thomas A Pollak #HyperemesisGravidarum #PerinatalMentalHealth #WomensHealth #ObGyn #Psychiatry #PerinatalPsychiatry To view or add a comment, sign in SSRIs & Brain Fertilizer: How They Boost BDNF Did you know your brain has its own fertilizer
