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Opioids

January 11, 2018 | Daily News

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

January 11, 2018 | Daily News

During the Senate health committee's Tuesday (Jan. 9) hearing on the opioid crisis, author and journalist Sam Quinones cautioned Congress against “acting too quickly” and looking for short-term solutions to the opioid crisis.

December 27, 2017 | Daily News

One lawmaker is upset FDA has yet to provide him details on how the agency will address use of unapproved non-opioid products and off-label uses of non-opioid products for acute and chronic pain treatment.

December 01, 2017 | Daily News

FDA on Thursday (Nov. 30) approved the first once-monthly buprenorphine injection -- a drug-device combination product -- to be used to treat moderate-to-severe opioid use disorder (OUD).

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar declined to commit to pushing Congress to appropriate at least $45 billion to fight the opioid epidemic during a Senate health committee hearing Wednesday (Nov. 29) on his nomination.

November 29, 2017 | Daily News

The Cato Institute is urging the government to stop promotion of abuse-deterrent formulations (ADFs) of opioids, saying they do more harm than good and promoting their use is unethical.

November 22, 2017 | Daily News

The head of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the CEO of a major opioid manufacturer are on the defensive over a New York Times editorial lambasting the recently announced public-private partnership between the pharmaceutical industry and the National Institutes of Health (NIH), which aims to support the development of non-addictive pain treatments.

November 21, 2017 | Daily News

FDA published final guidance on Tuesday (Nov. 21) that lays out how the agency will evaluate generic abuse-deterrent formulations (ADFs) of oral opioids and includes recommendations of the types of studies sponsors should conduct to show the generic ADF is no less abuse-deterrent than its reference listed drug (RLD).

November 20, 2017 | Daily News

The White House Council of Economic Advisors (CEA) announced Monday (Nov. 20) that the U.S. government has underestimated the cost of the opioid crisis, and that in 2015 the economic cost was $504 billion, or over six times more than the most recently estimated cost of the epidemic.

November 16, 2017 | Daily News

CMS is taking steps that would let Medicare Part D plan sponsors establish drug management programs for beneficiaries considered at risk for abuse of drugs identified as frequently abused under the Comprehensive Addiction and Recovery Act (CARA).

November 15, 2017 | Daily News

FDA has approved marketing approval of a device -- the first of its kind -- that can help provide patients with relief from opioid withdrawal systems, the agency announced Wednesday (Nov. 15).

November 15, 2017 | Daily News

FDA has approved the first drug in the United States embedded with an ingestible sensor that records when the medication is taken, the agency announced Monday (Nov. 13).

November 06, 2017 | Daily News

FDA will work with the Department of Homeland Security and local authorities in Puerto Rico to help a subset of drug and device manufacturers to jump the line for getting back on the electrical grid, FDA Commissioner Scott Gottlieb announced Monday (Nov. 6) at an Association for Accessible Medicines conference.