Following a routine review of the safety of the weight loss medicine Mysimba (naltrexone/bupropion), EMA recommends strengthening existing advice to minimise the risks from interactions between Mysimba and opioid-containing medicines (including painkillers such as morphine and codeine, other opioids used during surgery, and certain medicines for cough, cold or diarrhoea).
FDA announced the availability of a revised final guidance for industry entitled Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older, replacing the 2019 final guidance which discussed extrapolation to pediatric patients 4 years of age and older. This revised final guidance …
FDA recently added resources for the 2023 guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, to its Guidance Snapshot Pilot Program. The pilot includes a snapshot about the guidance, a recap podcast, and a podcast transcript for each of the highlighted guidances. The Guidance Snapshot program aims to increase awareness of and engagement with FDA guidance documents through visuals and plain language —and support the efficient application of their recommendations.
The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements.
The final guidance provides information on providing electronic submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act. These electronic submissions are referred to as over-the-counter (OTC) monograph submissions.
FDA issued a Federal Register notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments.” This notice establishes a public docket seeking substantive comments from interested parties on evaluating the immunogenicity risk of host cell proteins.
Artificial intelligence (AI) is generally being embraced in the pharma and life science sectors, but concerns around data accuracy and transparency remain, a new Elsevier survey reveals.
