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University of Maryland Center of Excellence in Regulatory Science and Innovation Survey Participation Opportunity

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the FDA, is conducting research to better understand how compounded products are used in clinical practice. Through completion of each survey, they aim to identify how you use these compounded products in your practice setting. This information will be used by the FDA to inform its development of the 503B Bulks List.

AAPM Issues Updated Position Statement on Research into the Use of Cannabinoids for Medical Purposes

More than 30 states as well as Washington D.C. have legalized cannabis for medical purposes, making it more accessible than ever before to patients throughout the country, including patients suffering from chronic pain. However, major systematic reviews on the use of cannabinoids for chronic pain have yielded conflicting conclusions regarding their effectiveness and safety.

“The lack of high quality, evidence-based clinical research into the use of cannabinoids for chronic pain, leaves both clinicians and patients at a distinct disadvantage when weighing the risks and benefits of considering cannabinoids as a pain treatment,” says AAPM Scientific Review and Guidelines Committee Co-Chair, Michael D. Osborne, MD.

On May 30 the AAPM Board of Directors approved an updated position statement on research into the use of cannabinoids for medical purposes, urging FDA to reschedule cannabinoids from Schedule I to Schedule II in order to facilitate needed research into the medical effectiveness, substance toxicity, and overall safety of these products for the treatment of pain. Read the full position statement.

“AAPM promotes individualized, patient-centered pain care delivered by a multidisciplinary team and employing the wide variety of therapies available to improve patient function and reduce suffering. In order for cannabinoids to become a trusted part of the pain management tool kit, it is essential to conduct further research,” says AAPM Scientific Review and Guidelines Committee Co-Chair, Randall Brewer, MD. “We believe that rescheduling tetrahydrocannabinol, an active ingredient in marijuana, will be a critical step in facilitating the necessary research to determine the role of cannabinoids in the treatment of chronic pain.”

FDA MedWatch Safety Alert: Ketorolac Tromethamine Injection by Sagent Pharmaceuticals: Recall – Due to Lack of Sterility Assurance

Sagent Pharmaceuticals, announced the voluntary nationwide recall of Lot Number M813513 of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.  

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Pain Medicine Journal
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AAPM

American Academy of Pain Medicine