[ Price : $8.95]
FDA grants priority review for an Axsome Therapeutics sNDA to treat Alzheimers disease agitation.[ Price : $8.95]
Two lengthy news service stories raise questions about FDAs approach to vaccines being espoused by CDER director Tracy Beth Heg an...[ Price : $8.95]
FDA issues a complete response letter to Sanofis NDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclero...[ Price : $8.95]
An inspection of a Dr. Reddy's India manufacturing plant raises significant GMP issues in a new Form FDA 483.[ Price : $8.95]
Lawmakers introduce bipartisan legislation in the House and Senate to provide a skinny label safe harbor for certain human and ani...[ Price : $8.95]
FDA warns Montague, MI-based Tower Laboratories about CGMP violations in its manufacture of finished drugs.[ Price : $8.95]
FDA warns Tampa, FL-based LiquidCapsule Manufacturing about repeated CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.