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Silver Spring
Joined July 2009

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  1. My new statement updating on ’s continued assistance to people of Puerto Rico following and : 🇵🇷

  2. Register! Regulatory Education for Industry (REdI): Prescription Drug Labeling Conference, Nov 1-2, 2017.

  3. working with to develop natural history models of rare diseases; make drug development more efficient

  4. investing $22 mil over next 4 yrs for 15 studies to help accelerate development of treatments for rare diseases

  5. We’re in Orlando for ! Stop by Exhibit #04 to learn about critical CDER trial guidances and regulations!

  6. We’re in San Diego for ! Stop by Exhibit #902 & learn how to stay up to date with important drug safety information.

  7. generic version of Copaxone (glatiramer acetate):

  8. Beware of tainted products marketed as dietary supplements. Learn how to identify and avoid them: .

  9. Oct 3

    . warns of risk of legal blindness with eye injections of compounded drugs containing vancomycin:

  10. FDA simplifies IRB review requirements for physicians seeking individual patient expanded access: .

  11. can cost 80-85% less than brand-name drugs. are often lower cost, but not lower quality.

  12. Sep 29

    A10: FDA has important role in addressing this crisis, esp re: ↓ # of new cases of addiction

  13. Sep 29

    A10: This public health emerg demands involvmnt of all parties. FDA is committed to doing our part

  14. Sep 29

    Q10: What can government and other organizations do to address the opioid crisis in the U.S.?

  15. Sep 29

    A9: Patients may req MAT indefinitely & should continue MAT as long as they benefit & use contributes to treatment goals

  16. Sep 29

    A9: FDA-aprvd MAT meds combined w/counseling & behavioral therapies is major pillar of federal response to opioid epidemic

  17. Sep 29

    Q9: What is Medication Assisted Treatment (MAT)? Why is MAT not just replacing one addiction with another?

  18. Sep 29

    A8: FDA just issued alert re:risks of combining certain meds w/MAT drugs; but MAT shldn’t be w/held

  19. Sep 29

    A8: FDA continues to promote safe adoption of medication-assisted treatment as a way to help more people overcome addiction

  20. Sep 29

    Q8: What are the current best strategies for treatment of addiction to opioids?

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