FDA Misses Deadline in Clash With Device-Makers Over Reviews
Published: Jan 18, 2012
U.S. regulators haggling with medical-device makers over how much it will cost to speed up product reviews starting this year missed a legal deadline to submit a proposal for congressional approval. Under a 2007 law, the companies, led by Johnson & Johnson and Medtronic Inc., were charged $295 million over five years to get products such as hip implants and heart stents reviewed in a timely manner. The law, set to be reauthorized this year, mandates that the agency submit a new agreement to U.S. lawmakers by Jan. 15.