TY - JOUR AU - Sancar, Feyza AB - News & Analysis News From the Food and Drug Administration Robotically Assisted Surgical Devices acting director of the FDA’s Division of Psy- vomiting,andfeelingdrunk.Esketaminemay Raise Caution chiatry Products, said in a statement. pose additional risks for patients with poorly The FDA has warned that robotically as- Marketed as Spravato, the drug is indi- controlled hypertension or preexisting aneu- sisted surgical devices haven’t been estab- cated for patients whose depressive symp- rysmal vascular disorders and is contraindi- lished as safe and effective to treat or pre- toms haven’t improved after treatment with cated for pregnant or breastfeeding women. vent breast or cervical cancers. at least 2 oral antidepressant monothera- Although the evidence is limited, the pies. It is intended for use with a newly ini- Agreement to Regulate Cell-Based agency also cautioned that using the de- tiated oral antidepressant. Meat Products vices for these indications may be associ- Theapprovalwasbasedon4phase3ran- As lab-to-table beef and poultry products inch closer to reality, the FDA announced a atedwithreducedlong-termsurvival.Forex- domizedclinicaltrials,only2ofwhichdemon- ample, a recent prospective randomized strated esketamine’s clinical effectiveness in formal agreement to jointly regulate them. According to the agreement, the FDA clinical trial found that patients who under- treatingpatientswithTRD.In1trial,patientsre- went laparoscopic or robotically assisted ceiving TI - Agreement to Regulate Cell-Based Meat Products JF - JAMA DO - 10.1001/jama.2019.3831 DA - 2019-04-16 UR - https://www.deepdyve.com/lp/american-medical-association/agreement-to-regulate-cell-based-meat-products-6WZtQAanGf SP - 1449 EP - 1449 VL - 321 IS - 15 DP - DeepDyve ER -