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August 29, 2018 | Daily News

FDA will scrap a 2014 guidance document on pain drug development and replace it with four, less-onerous guidance documents over the next six to 12 months in a bid to spur drug development, FDA Commissioner Scott Gottlieb says in a Wednesday (Aug. 29) statement.

August 29, 2018 | Daily News

Senate Republicans have cleared the Senate opioid package and are now awaiting for Democrats to clear it on their side, Senate Majority Leader Mitch McConnell (R-KY) said at a press conference Tuesday (Aug. 28).

August 28, 2018 | Daily News

FDA has sent warning letters to four online networks operating 21 websites for illegally marketing unapproved, misbranded opioids, including tramadol, the agency announced Tuesday (Aug. 28).

August 23, 2018 | Daily News

FDA has contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a consensus study and issue a report on what evidence is needed to ensure clinical practice guidelines for opioid prescribing for acute pain are sufficient and how to generate said evidence, agency head Scott Gottlieb announced Wednesday (Aug. 22).

August 20, 2018 | Daily News

Sen. Edward Markey (D-MA) is calling for an overhaul of FDA's safety protocols for transmucosal immediate-release fentanyl (TIRF) products, pointing to data suggesting the agency has known that its current Risk Evaluation and Mitigation Strategies have allowed widespread off-label prescribing of the risky opioid product.

August 16, 2018 | Daily News

President Donald Trump called on Attorney General Jeff Sessions to bring a federal lawsuit against opioid makers and distributors rather than just joining state suits, and to explore ways to stop opioids from coming in from China and Mexico, according to a White House press pool report from Thursday (Aug. 16).

August 16, 2018 | Daily News

The Drug Enforcement Administration (DEA) is proposing to cut manufacturing quotas for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl by an average of 10 percent for 2019 compared to the 2018 production quotas, the agency announced Thursday (Aug. 16).

August 16, 2018 | Daily News

A veterinary pain management expert is concerned about potential lack of access to opioids in the veterinary medicine space that could be caused by attempts to curb the opioid epidemic.

August 16, 2018 | Daily News

FDA has put veterinarians who prescribe opioids to treat pain in animals on notice that pain medications prescribed for pets could be misused by people.

August 13, 2018 | Daily News

Marijuana policy reform groups, in comments sent to FDA, highlight the potential for medical marijuana to help curb the opioid epidemic, mainly by giving patients with chronic pain an alternative to opioids and helping to reduce prescribing rates.

August 09, 2018 | Daily News

The American Cancer Society Cancer Action Network (ACS CAN) says the recent spate of state legislation and policy proposals responding to the opioid crisis are creating barriers to treatment and relief for cancer patients and others with chronic pain.

August 06, 2018 | Daily News

FDA in a draft guidance published Monday (Aug. 6) lays out new types of endpoints -- beyond complete abstinence from drug use -- that can be used to develop and assess the efficacy of medication-assisted treatment (MAT) for opioid use disorder and be included on product labeling.

August 03, 2018 | Daily News

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation.

July 13, 2018 | Daily News

Chronic pain patients, patient representatives and caregivers lambasted the Centers for Disease Control and Prevention’s opioid prescribing guidelines at an FDA meeting Monday (July 9), saying the guidelines have caused doctors to be reluctant to prescribe opioids and have led to patients being involuntarily weaned off much-needed medications.

July 13, 2018 | Daily News

The chronic pain patient community argued that policies to lower opioid prescribing rates are having a negative effect on patients, speaking at an FDA meeting Monday (July 9).

July 13, 2018 | Daily News

FDA will hold a two-day scientific conference in September to discuss how sex and gender influence opioid and tobacco misuse and abuse, the agency announced in the Federal Register Friday (July 13).

July 06, 2018 | Daily News

While tech companies are uniquely positioned to positively affect public health with regard to the opioid crisis, the industry remains somewhat hesitant to take on the role as content police, one policy expert told Inside Health Policy.

July 05, 2018 | Daily News

Facebook delivered a 748-page document to House lawmakers describing its current process for taking down flagged content and detailing its efforts to ban certain search terms and more quickly remove inappropriate content, but also said its response to the opioid crisis is a work in progress -- a message that echoes Facebook Co-founder and CEO Mark Zuckerberg's comments during a recent Energy & Commerce Committee hearing.

June 27, 2018 | Daily News

FDA on Wednesday (June 27) convened a summit with other federal agencies and more than 15 internet companies, patient advocacy organizations and universities to talk about how to stem the online sale and purchase of illicit opioids.

June 26, 2018 | Daily News

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee on Tuesday (June 26) voted 14-3 that efficacy, safety and risk-benefit data for a new oxycodone medicine -- Pain Therapeutics’ Remoxy Extended Release (ER) -- did not support the drug’s approval.