Newsletter - January 17, 2019
FDA Expects More Than 200 new INDs for Cell Therapy Products Next Year
In a news release this week, FDA leaders announced that they are forging ahead with increased enforcement of IND and BLA rules on cell therapy companies and expect to receive hundreds of new INDs within months. FDA estimates that by next year it will receive more than 200 new INDs...Read More
FDA Continues Critical Audits During the Government Shutdown
FDA announced yesterday that it has called about 400 inspectors back to their job, without pay. About two-thirds of these inspectors will continue audits of drug, device and biologics manufacturing facilities, and the rest for food inspections. FDA emphasized that all inspections or audit...Read More
FDA Expects More Than 200 new INDs for Cell Therapy Products Next Year
In a news release this week, FDA leaders announced that they are forging ahead with increased enforcement of IND and BLA rules on cell therapy companies and expect to receive hundreds of new INDs within months. FDA estimates that by next year it will receive more than 200 new INDs...Read More
FDA Continues Critical Audits During the Government Shutdown
FDA announced yesterday that it has called about 400 inspectors back to their job, without pay. About two-thirds of these inspectors will continue audits of drug, device and biologics manufacturing facilities, and the rest for food inspections. FDA emphasized that all inspections or audit...Read More
