[10-2-2024] FDA continues to advise consumers not to purchase or use Body Shape Weight Loss System, a product promoted and sold for weight loss. This product […]
TOPLINE: Adjuvant chemotherapy after removal of the affected eye improves outcomes in children with unilateral retinoblastoma who have high-risk histopathologic features that predispose them to metastases […]
Compounding drugs when the drug is in shortage FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded […]
TOPLINE: Women with premature ovarian insufficiency (POI) have a 2.6 times higher prevalence of severe autoimmune diseases before diagnosis and a 2- to 3-fold increased risk […]
The table below lists all the documents and supportive files applicable to eCTD submissions to CDER and CBER. Version History Submission Standards for eCTD v4.0 Validation […]
People with hidradenitis suppurativa (HS) who have overweight or obesity may benefit from adjunctive treatment with the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic, Wegovy), […]
TOPLINE: Over 90% of patients with symptoms of bronchitis, sinus infections, sore throats, colds or flu, or diarrhea expect antibiotic prescriptions. Visiting a public clinic, lower […]
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