This guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or overweight.
New interim results from a Phase IIa trial suggest that a gel formulation could address skin toxicities (skin, scalp, nails) associated with epidermal growth factor receptor inhibitors (EGFRi) as a cancer treatment.
U.S Food and Drug Administration (FDA) announced the availability of a draft guidance M15 General Principles for Model-Informed Drug Development. Developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), this draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD) and provides recommendations on MIDD …
This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. The guidance describes the characteristics of the specific source publications contained in firm-initiated communications that fall within the …
FDA issues final guidance on communicating scientific information about unapproved uses Read More »
U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. This is the first guidance the agency has issued on the use of AI for the development of drug and biological products.
Roche and Innovent Biologics, Inc. have agreed to collaborate to advance development of an innovative DLL3-targeted antibody drug conjugate (ADC) candidate. Innovent shared that this collaboration focuses on advancing treatment options in advanced small cell lung cancer.
The National Institute for Health and Care Excellence (NICE) has recommended the first drug for NHS use to prevent cisplatin-induced hearing loss (ototoxicity) in children and young people between the ages of one month and 17 years old. Pedmarqsi ® (anhydrous sodium thiosulfate) is indicated for these children who have localised, non-metastatic, solid tumours.
FDA is announcing the availability of a draft guidance for industry entitled “Study of Sex Differences in the Clinical Evaluation of Medical Products.” Differences in physiology between females and males can lead to differences in disease manifestation, pharmacokinetics, pharmacodynamics, and response to treatment. Analyzing sex-related differences in medical product response is an important component of assessing product safety and …
