During the week of March 3-9, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
The Food and Drug Administration reclassifying absorbable lung biopsy plugs as Class II devices that do not require premarket approval,in a final rule that takes effect April 9. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. The devices will be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling,
On March 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The $2.5 billion requested for the Food and Drug Administration in the Obama administration’s fiscal year 2015 budget proposal “falls far short of what the agency needs to fulfill its responsibilities,” said the Alliance for a Stronger FDA on March 5. The advocacy group, which represents a broad range of nearly 200 non-profits, trade associations and companies, said the 1% increase over FY 2014 levels isn’t nearly enough, and will weaken the agency. “Substantial increases are needed to support FDA’s critical mission,” it said.
On March 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Feb. 24 - March 2, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
The Food and Drug Administration’s Center for Biologics Evaluation and Research will be moving from its current facilities in Rockville and Bethesda, Md., to FDA’s main White Oak campus in Silver Spring, Md., said the agency in a Federal Register notice. The move will begin around May 1, and should take about 8 weeks, until around July 1, it said. FDA said it will post new addresses for CBER as they become available (here).