JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Healthline

FDA Approves ‘New’ Sunscreen Ingredient Used in Europe and Asia for Years

Bemotrizinol (PARSOL Shield), an advanced sunscreen filter that has long been used in Europe and Asia, has been approved for ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...

FDA Issues Complete Response Letter for AbbVie’s Fast-Acting Neurotoxin TrenibotE; Spokane dermatologist Dr. Philip Werschler on What the Letter Means

The agency’s letter cited manufacturing-related items and raised no safety or efficacy concerns. Werschler, a Spokane dermatologist who has ...