Day: January 17, 2019

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 will be at “high-risk” manufacturing facilities with means that the efforts … Read more

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 for such products each year, … Read more