USA – FDA updates generic transdermal and topical delivery systems guidances
The US Food and Drug Administration (FDA) on Wednesday issued two revised draft guidances for generic drug submissions that use transdermal and topical delivery...
USA – FDA outlines risk-based approach to monitoring clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring...
USA – FDA updates guidance on reporting manufacturing disruptions for finished products and APIs
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or...
USA – FDA withdraws pre-term birth drug Makena
Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena...
USA – FDA issues last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
USA – Guidance details review process for pediatric research not approvable by an IRB
The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process...
USA – FDA to require mail-back envelopes for unused opioids
Drugmakers will soon have to provide patients with postage-paid envelopes to send back unused opioids for safe disposal under a new requirement announced by...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
USA – QMSR: Start now to be ready for final rule, slated for December
The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality...
USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
