Public Meeting: Exploring Naloxone Uptake and Use (July 1-2)

FDA in collaboration with the National Institutes of Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, is announcing a scientific workshop to initiate a public discussion about issues surrounding the uptake of naloxone in certain medical settings – such as on ambulances and in association with prescriptions for opioids – as well as outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. Academia, government, industry experts, and patient advocates will discuss which populations are at risk for opioid overdose and how public health groups can work together to use naloxone to reduce the risk of overdose. We will also explore legal, regulatory, logistical and clinical aspects related to making naloxone more widely available.

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 7-8)

The committees will discuss the results of post marketing studies evaluating the misuse and/or abuse of reformulated Oxycontin (oxycodone hydrochloride) extended-release tablets, supplemental new drug application (sNDA) 022272, manufactured by Purdue Pharma L.P. The committees will discuss whether these studies have demonstrated that the reformulated Oxycontin product has had a meaningful impact on abuse of Oxycontin.

Oncologic Drugs Advisory Committee (Jul 9)

The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

Public Meeting: Medical Device User Fee Reauthorization (Jul 13)

FDA will hold a public meeting to gather initial input on reauthorization of the Medical Device User Fee program, as required by section 738A of the Federal Food, Drug, and Cosmetic Act. Additional information and Federal Register announcement available.

Public Meeting: Prescription Drug User Fee Reauthorization (Jul 15)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in developing recommendations for the next PDUFA program (FY2018-2022).

Public Workshop: Robotically-Assisted Surgical Devices – Challenges and Opportunities (Jul 27-28)

The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS technologies. The participants of this workshop will discuss current challenges and opportunities related to RAS devices and address clinical, technical and training questions related to the safe and effective use of these devices.

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