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FDA, CBP Sign Agreement to Enhance Cooperation on Stopping Dangerous Drugs
April 4, 2019 |FDA

The Food and Drug Administration and CBP signed an agreement April 4 to increase cooperation on preventing “illegal and harmful products” from entering the U.S. via ports of entry and international mail facilities, FDA said in a press release. “Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate,” FDA Commissioner Scott Gottlieb said. Under the agreement, FDA and CBP “will expand how information is shared between the agencies to identify trends which can target future entries. This may include general data points on frequent countries of origin, as well as specific products and volumes of packages at each location,” the release said. They will also “enhance coordination around efforts to identify violative packages and develop new targeting and enforcement strategies at Ports of Entry,” FDA said.

FDA Proposes to Lower Amount of Fluoride Allowed in Bottled Water
April 3, 2019 |FDA

The Food and Drug Administration is proposing to amend is standard for bottled water to lower the amount of fluoride that can be added to domestic and imported bottled water. FDA is proposing to set the limit at 0.7 milligrams per liter. The limit for imported bottled water is currently 0.8 mg/L. Comments on the proposal are due June 3.

FDA Moves to Risk-Based Model for Biologics Facility Inspections
April 1, 2019 |FDA

The Food and Drug Administration is again issuing a final rule amending its regulations on inspections of biologics facilities to remove a requirement that biologics facilities be inspected every two years so that FDA could instead follow more risk-based procedures. Instead, the timing of facility inspections will depend on the level of risk presented, FDA said. The final rule also removes FDA inspector duty requirements from the regulations altogether, as they are already outlined in the underlying statutes. FDA had issued the changes as an interim final rule in January 2018, before it had to withdraw it in May to respond to adverse comments. The final rule takes effect May 2.

FDA Proposes to Streamline Regulations for Radiological Products
March 29, 2019 |FDA

The Food and Drug Administration is proposing to amend its radiological health regulations to “reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices,” it said in a notice. Among other things, FDA’s proposed rule would amend record-keeping and reporting requirements for electronics and medical devices by reducing some annual report and test record requirements, and cut back on some regulatory requirements for uncertified products incorporated into an electronic product that is then certified by its manufacturer. Comments are due July 1.