new drug application

What are GRAS ingredients?Another way cosmetics insure their safety is by adhering to a list of substances known as GRAS ingredients. GRAS stands for “Generally Recognized as Safe” and indicates ingredients that are currently widely used in the marketplace without safety issues.
FDA accepts NDA for first 'digipill'Proteus Digital Health along with the pharmaceutical company, Otsuka, has submitted the first Digital Medicine New Drug Application (NDA) for the combination tablet of Abilify (aripiprazole) embedded with a Proteus ingestible sensor.
FDA grants priority review to expand use of BrilintaThe FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.
FDA seeking more info on Avedro’s corneal cross-linking NDAAvedro Inc. has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for riboflavin ophthalmic solution/KXL System to treat keratoconus and corneal ectasia after refractive surgery.
New outcomes data to be included on Xeljanz labelsFDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.
Investigational fertility treatment approved by FDAThe US Food and Drug Administration approved the new drug application (NDA) for Merck’s investigational fertility treatment corifollitropin alfa. Merck is seeking approval for the use of corifollitropin alfa in controlled ovarian stimulation (COS). If approved, the drug would be the first sustained follicular stimulant available in the United States.