New Novartis Medicine Adakveo® (crizanlizumab) Approved by FDA to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease

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FDA

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 prac...
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Medical Device Safety in the Real World: Tapping EHR Data

Before any medical device reaches the market, it has to meet certain safety standards set by the Food and Drug Administration. But these standards are just a first step -- any number of things can happen when the devices hit the clinic.

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FDA

FDA Market Clears Erchonia’s FX 635 Laser for Chronic Low Back Pain

Erchonia Corporation announces another successful clinical trial that has resulted in the granting of an FDA 510(k) market clearance for chronic low back pain of musculoskeletal origin. This grants another first for Erchonia, which started the low-level laser category in January 2002. That year, the FDA issued its first 510(k) market clearance for any low-level laser based on Erchonia's clinical trial for chronic neck and shoulder pain.

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First Utahns Treated in Nationwide FDA-Allowed Clinical Study of Locally Developed Cell Therapy for Chronic Low Back Pain

A clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).

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FDA Approves First Generics of Lyrica

The U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of ...
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FDA MedWatch Safety Alert: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products

 RXQ Compounding, LLC ("RXQ") is voluntarily recalling all sterile human and animal products within expiry to the user level due to lack of sterility process assurance associated with the production of the Company's...
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FDA

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...
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FDA Announces Public Meeting to Discuss Safety and Utility of Higher-Dose Opioid Analgesics

FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient set...
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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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FDA MedWatch Safety Alert: Fentanyl Transdermal System by Alvogen - Recall: Due to Product Mislabeling

 Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h.
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FDA Identifies Harm Reported From Sudden Discontinuation of Opioid Pain Medicines

The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide. 

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