During the week of March 4-10, 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 will hold a public conference in Cincinnati May 1-3, in conjunction with Xavier University, on medical devices. The conference will include presentations from FDA officials and small group breakout sessions. Topics for discussion include a Center for Devices and Radiological Health outlook; European Union regulations; unique device identification; global product strategy; and FDA inspections. Pre-registration is available until April 9 (here), although early registration ends March 13. Registration will also be available on-site, FDA said.
The Food and Drug Administration said a guidance for industry is now available on scored tablet drug applications and labeling. The document, titled “Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation” (here), discusses guidelines and criteria for applications to support approval of a scored tablet, as well as nomenclature and labeling for approved scored tablets, FDA said.
On March 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 7 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The Food and Drug Administration announced the availability of a draft guidance on medical product labeling related to latex content. FDA said it issued the guidance because manufacturers have included terms like “latex-free” or “does not contain latex” on medical product labeling, but such statements are not specific enough, not scientifically accurate, and should not be included in medical product labeling, the agency said. The guidance recommends accurate labeling that can be used by manufacturers that which to convey no natural rubber was used in a product. Comments on the guidance are due by June 10.
The Food and Drug Administration issued its weekly Enforcement Report for March 6 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration said a guidance is available on administrative detention of food. The FDA updated a previous guidance to make it consistent with a recent final rule on administrative detention regulations. Under the final rule, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. Decisions on whether FDA has a “reason to believe” a food is adulterated or misbranded are made on a case-by- case basis because such decisions are fact specific. The guidance is here.
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 is making technical amendments to its regulations on food and color additives. Changes include corrected misspellings of chemical names, a corrected table entry on the melting point of some nylon 2T resins, and amendments to several provisions to update office names and street addresses. The changes are effective March 7.