Articles for “FDA”

FDA

Date Range:

Author:

Topic:

Refine Category Search

Clear Terms

Search Primer

Multi-word term: Place inside quotes to ensure an exact match together (e.g. "China import").

Term list: Separate terms with spaces, not commas or semicolons to find either word (e.g. AD/CVD antidumping).

Acronyms: Use all capital letters (e.g., ACE).

Required term: If a term must be included in any resulting articles, prefix it with a plus sign (e.g., CBP +releases).

Excluded term: If a term should be excluded from any articles being found, prefix it with a minus sign (e.g., -ruling).

Singular form: Use the singular form when doing multi-word terms (e.g. "russian export control" instead of "russian export controls").

Shortest word form: When you have different word forms in a quoted term, include the shortest version if it is the last part of the expression (e.g., "entity list" instead of "entity listing" or "entity listed").

New and Revised FDA Import Alerts for July 16

July 17, 2018 |FDA

On July 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for July 13

July 16, 2018 |FDA

On July 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for July 12

July 13, 2018 |FDA

On July 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Former FDA Official Warns of Lack of Funding for FSMA Import Mandates

July 13, 2018 |FDA

A shortfall in funding for the Food and Drug Administration’s food import safety system could be exacerbated by the agency’s meager fiscal year 2019 budget request, said Michael Taylor, former deputy commissioner of FDA’s Center for Food Safety and Nutrition, in a recent editorial in Food Safety News. “The president’s 2019 budget request for the Food and Drug Administration, now pending in Congress, is essentially flat for food safety, which means a decrease in actual purchasing power due to rising costs for delivering services,” Taylor, who is now co-chair of the board for consumer advocacy group Stop Foodborne Illness, said in the July 9 opinion piece. “In contrast, for FDA’s medical product programs, the 2019 budget requests an increase of more than $400 million,” he said. “This imbalance in investment priorities occurs despite the fact that Congress has appropriated only about half of what the Congressional Budget Office estimated would be needed to successfully implement [the Food Safety Modernization Act (FSMA)].” The funding shortfall “will have consequences” for imports, where FDA has “put key pieces of the new system in place but is far short of the resources needed to fully implement the FSMA import mandate,” he said.

FDA Updates Compliance Program Manual for Infant Formula

July 13, 2018 |FDA

Updates to the Food and Drug Administration’s compliance program for infant formula took effect July 10, according to a revised manual recently posted to the FDA website. The updated manual includes instructions for FDA inspectors on inspection of foreign infant formula facilities and procedures at time of entry for imports of infant formula. Infant formula may only be admitted if its manufacturer has complied with notification and submission requirements. Entries of infant formula that are U.S. goods returned are subject to additional scrutiny, as is formula marked “export only” that is re-imported into the United States.

New and Revised FDA Import Alerts for July 11

July 12, 2018 |FDA

On July 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for July 11

July 12, 2018 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 11 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

New and Revised FDA Filer Evaluation Outcomes for July

July 12, 2018 |FDA

The Food and Drug Administration posted its updated list of filer evaluation outcomes for July 2018. The frequency of filer evaluations depends on the number of lines filed by the company. An outcome of "paperless" means FDA has determined that electronic filing is appropriate, while "corrective action plan" means FDA has found an elevated error rate and has directed the filer to fix the issue, and "dual-mode filer" means the company has failed to implement corrective action plans and has been returned to dual-mode (paper and electronic) filing. The following filer evaluation outcomes were updated in FDA's July 2018 list:

New and Revised FDA Import Alerts for July 10

July 11, 2018 |FDA

On July 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Proposes Change to Labeling Requirements for Food Sold in Vending Machines

July 11, 2018 |FDA

The Food and Drug Administration is proposing to amend its regulations to increase the type size of calorie declarations on packaging of food sold in vending machines. Under the proposed rule, type size for front of package calorie declarations on food sold from glass front vending machines would have to be at least 1.5 times size of the net weight declaration. The current requirement is 50% of the size of the largest printed matter on the label. FDA is proposing the change to “reduce regulatory burdens that the vending and packaged foods industries shared with us after the final rule implementing the vending machine labeling requirements” was issued in 2014. Comments are due Sept. 25.