Events and Speeches for the Commissioner and FDA Leadership
Monday, 8/29 –
FDA Commissioner Robert Califf, M.D., is delivering open remarks at the public workshop, Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c)
. The public workshop is a dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease. The ultimate purpose of identifying and qualifying these outcomes for regulatory purposes would be to continue to support the development of novel therapies that directly address the needs of patients. There will be an opportunity for questions and answers following each presentation. The workshop is taking place at 9 a.m. on the FDA’s White Oak Campus, Silver Spring, Md.
On the Web
In Case You Missed It:
Wednesday, 8/24 –
Consumer Update: What to Know When Buying or Using a Breast Pump
. If you’re giving your baby breast milk, you probably know there can be times when a breast pump can come in handy. Breast pumps are medical devices regulated by the FDA. They can be used to maintain or increase a woman’s milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch on more easily. And there are important safety considerations if you use one.
Wednesday, 8/24 –
FDA Voice Blog: FDA Is Preparing Guidances that Will Help Food Companies Prevent Foodborne Illness
. When the FDA was
drafting and seeking public comment on the rules that will implement the FDA Food Safety Modernization Act (FSMA), it promised it would do all it could to help the regulated industry understand and meet the new requirements, since these new standards will ultimately transform the nation’s food safety system.
Monday, 8/22 – FDA Statement on Medical Device User Fee Agreement (MDUFA)
: The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
Monday, 8/22 –
News Release: FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury
. The FDA permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.