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The overall quality of data and risk of potential bias in them should be top of the mind for European sponsors who want to employ real-word data (RWD) in non-interventional studies (NIS), according to a reflection paper released by the European Medicines Agency. Read More
The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Sciences (OTS), highlighting activities that span dozens of drug approvals and guidances from developing AI-enabled software prototypes to identify adverse drug events. Read More
In this edition of Quick Notes are drug approvals to treat hemophilia B, rare genetic disorder WHIM, cervical cancer, cluster seizures in children with epilepsy and a new formulation of a drug for movement disorders. Read More
This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
Using Sarepta’s treatment for Duchenne muscular dystrophy (DMD) as an example, a researcher from the Institute for Clinical Review (ICER) said in a recent article that the FDA should be cautious in granting full approval to drugs that fail confirmatory tests. Read More
“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of Internal Medicine. Read More
This edition of Quick Notes reviews the FDA’s approval of Medtronic’s closed-loop rechargeable spinal cord stimulator, Abbott’s below the knee Everolimus Eluting Resorbable Scaffold System, an integrated continuous glucose monitor, and clearance of AEYE Health’s AI that diagnoses referable diabetic retinopathy. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT). Read More
Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a research letter published in JAMA Network Open. Read More
SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux saw a Class I recall for an antibiotic sensitivity test kit that could produce inaccurate results. Read More
A recent Warning Letter to www.dashpct.com, a Malaysian online marketer, should send a clear message that the agency is getting tough on companies selling unapproved and misbranded semaglutide (Rybelsus/Ozempic/Wegovy). Read More