FDA Explains Plans for New Pharmaceutical Quality Assessment System

USA – FDA Explains Plans for New Pharmaceutical Quality Assessment System

As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing...
FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

USA – FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents,...
When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates

USA – When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates

A new study in JAMA Network Open finds that drugs and medical devices approved by the US Food and Drug Administration (FDA) based solely on non-randomized...
FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

USA – FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

The US Food and Drug Administration (FDA) said Monday that an inspection of an outsourcing facility uncovered information about 4,202 adverse events linked to...
FDA asks drug, biologics makers to use UCUM in electronic submissions

USA – FDA asks drug, biologics makers to use UCUM in electronic submissions

The US Food and Drug Administration (FDA) on Friday announced its support for the latest set of Unified Code for Units of Measure (UCUM)...
FDA approvals of new cancer drugs have doubled in this decade

USA – FDA approvals of new cancer drugs have doubled in this decade

n the 1980s, only 4% of new drugs approved by the FDA were cancer treatments. But since 2010, cancer drugs have claimed 27% of...
Cloud-based tracking system monitors drug adherence

USA – Cloud-based tracking system monitors drug adherence

Meet ReX, a drug-dispensing device designed to help patients remember to take their pills. About the size of a coaster, ReX is part of a...
FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to Children

USA – FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to...

The US Food and Drug Administration (FDA) on Thursday finalized guidance providing recommendations for developing drugs to treat pediatric patients with partial onset seizures...
FDA issues final guidance on de novo approvals

USA – FDA says widening probe on generic drug impurities

The U.S. Food and Drugs Administration said on Wednesday it was expanding its investigation into impurities in U.S. generic drugs beyond a class of...
FDA asks drug, biologics makers to use UCUM in electronic submissions

USA – FDA Finalizes Guidance on Placebos and Blinding for Cancer Trials

The US Food and Drug Administration (FDA) on Wednesday finalized guidance recommending that drugmakers only use placebos in cancer clinical trials in select circumstances...

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