Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug
On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large amendment package. The bill includes S.Amdt. 3964, an amendment introduced by Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) that provides
The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of
The Food and Drug Administration (FDA) recently published annual bioresearch monitoring (BIMO) inspection metrics for fiscal year (FY) 2014. These data show not only an increase in the total number of BIMO inspections in recent years, but also an increase in the number of certain types of violations found during each inspection.
On May 6, 2014, FDA issued a proposed rule to implement the agency’s new administrative authority to destroy drugs valued at $2,500 or less that have been refused admission during importation into the United States1. FDA is requesting that interested parties submit comments on the proposed rule by July 7, 2014. FDA developed the proposed
On November 26, the Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a producer of nuts, and nut and seed spreads. Notably, this is the first time FDA has used its registration suspension authority, which was established by Section 102(b) of the FDA Food Safety Modernization Act (FSMA). Significantly, this
FDA and the White House Office of Management and Budget (OMB) were recently sued by two consumer advocacy groups for failing to meet several statutory rulemaking deadlines in the FDA Food Safety Modernization Act (FSMA). In late 2011, FDA submitted four proposed rules implementing FSMA to OMB for review. The proposed rules cover Preventive Controls
While the Ninth Circuit’s recent ruling in POM Wonderful v. Coca-Cola has received attention for its holding on preemption, the decision provides interesting statements in the technical realm of the FDA’s type-size requirements for statements of identity in food labeling. The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate