sábado, 21 de septiembre de 2019

FDA In Brief: FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-seeks-input-development-and-evaluation-abuse-deterrent-formulations-central-nervous?utm_campaign=091919_FIB_FDA%20seeks%20input%20on%20abuse-deterrent%20formulations%20of%20stimulants&utm_medium=email&utm_source=Eloqua


FDA In Brief: FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants 


Today, the U.S. Food and Drug Administration issued a Federal Register notice to establish a public docket to receive comments from interested parties, including patients, patient advocates, health care professionals, academics, researchers, the pharmaceutical industry and other government entities on considerations related to the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse.

Although the FDA has approved multiple ADF opioid analgesic products with language in the drug labeling stating that these products are expected to deter abuse via specific routes of administration, the agency has not...

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