FDA clears a Xtant Medical Holdings 510(k) for the Irix-C cervical cage for use with autograft or allograft and the expansion of the range of levels a...
Regulatory consulting firm Greenleaf Health hires two former senior FDA officials former Office of Regional Operations director David Elder and forme...
House Republican leaders write FDA commissioner Robert Califf and other federal agency heads to caution them against finalizing pending rules or regul...
Two Morgan, Lewis attorneys outline questions and concerns raised by a recent FDA draft guidance on clinical evaluation of software as a medical devic...
Experts surveyed to update a Tufts Center for the Study of Drug Development report on pediatric drug studies see efforts moving in the right direction...
FDA warns Japans Sekisui Medical Co. about CGMP and data integrity issues in its manufacturing of active pharmaceutical ingredients.
The Federal Trade Commission announces a new Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.
Contract research organization executives at Premier Research discuss ways in which patient advocates play a lead role with FDA and industry in develo...