Gottlieb's FDA

FDA published five neurological disease-specific guidance documents as part of its efforts to clearly communicate scientific and regulatory information more efficiently through practical, more concise guidance, FDA Commissioner Scott Gottlieb announced Thursday (Feb. 15).

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

FDA, working with the Nuclear Regulatory Commission, approved NorthStar Medical Radioisotopes' RadioGenix System, a “novel manufacturing system” to produce a non-uranium version of radioisotope technetium-99m (Tc-99m), a diagnostic agent used in nuclear imaging studies to detect cancer and coronary artery disease, FDA and Commissioner Scott Gottlieb announced in simultaneous press statements on Thursday (Feb. 8).

FDA may continue in 2018 to use warning letters as its primary means of regulating cosmetics, according to one law firm whose recent report shows that 2016 and 2017 represented a 10-year high in the number of warnings sent to brands regarding drug claims made for topical skin care products marketed as cosmetics.

The top Republicans on the House Energy & Commerce Committee are requesting FDA create a contingency plan by next month to deal with the possibility of a heparin shortage.

FDA Commissioner Scott Gottlieb told legislators Tuesday (Jan. 30) that FDA will take a risk-based approach to both the yet-to-be-finalized 503B-lite category of compounders and the new model agreement between states and FDA on oversight of compounders that ship products out of state.

FDA and the Department of Agriculture finalized an agreement Tuesday (Jan. 30) to formally cooperate on produce safety, biotechnology regulation and oversight of food facilities where they share jurisdiction.