New drug options, risk factors added to U.S. heart guidelines

USA – New drug options, risk factors added to U.S. heart guidelines

Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen...

Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who...
FDA Issues Guidance on Dried Plasma Products for Blood Transfusions

USA – FDA Issues Guidance on Dried Plasma Products for Blood Transfusions

The FDA offered recommendations for developers of dried plasma products used in blood transfusions in new draft guidance. Sponsors using dried plasma from pooled donations...
FDA Finalizes Guidance on Developing Fixed Combination Hypertension Drugs

USA – FDA Finalizes Guidance on Developing Fixed Combination Hypertension Drugs

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing fixed-combination drugs to treat hypertension. The guidance, which finalizes a draft version released in...
Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance

USA – Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance

The conducting of meta-analyses to evaluate safety questions presents a unique opportunity to detect and quantify the risk of a safety event and may...
Hepatitis B Virus Drug Development: FDA Offers Draft Guidance

USA – Hepatitis B Virus Drug Development: FDA Offers Draft Guidance

With an aim to assist sponsors looking to develop hepatitis B virus (HBV) treatments, the US Food and Drug Administration (FDA) on Thursday released...
Vanda Lands OPDP Warning Letter Over Risk Info on Website

USA – Vanda Lands OPDP Warning Letter Over Risk Info on Website

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week sent a warning letter to Vanda Pharmaceuticals for failing...
U.S. FDA Approves TherapeuticsMD's Menopause Drug

USA – U.S. FDA Approves TherapeuticsMD’s Menopause Drug

The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD's oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats,...
FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

USA – FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based...
FDA warns 465 websites selling unapproved opioids, drugs for cancer, HIV

USA – FDA warns 465 websites selling unapproved opioids, drugs for cancer, HIV

The FDA sent warning letters this month to seven networks operating 465 websites that were selling potentially dangerous, unapproved versions of opioid, antiviral and oncology...

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