LEGISLATIVE UPDATE

Wednesday, February 20

CMS: Democratic Health Leaders Send Letter to CMS Laying Out Concerns with the Administration’s Proposed Health Insurance Market Rules

Thursday, February 21

Medicaid: House Energy & Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) Warn Administration to Stop Allowing Harmful Medicaid Waivers


REGULATORY UPDATE

Monday, February 18

FDA: FDA Announces Opportunity for Public Comment on Labeling of Nonprescription Human Drug Products

Tuesday, February 19

FDA: FDA Issues Final Rule to Establish Criteria for and Identify List of Bulk Drug Substances

  • FDA Announces Availability of Draft Guidance for Competitive Generic Therapies
  • FDA Announces Availability of Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry

FDA: Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D. Statement Cautioning Consumers Against Receiving Donor Plasma Infusion

NIH: Researchers Discover a Potential Biomarker for Psychosis

  • Preclinical Study Finds Common Form of Brain Cancer May be Treated by Radio and Chemotherapy
  • Newly Published Study Suggests Monthly Buprenorphine Injections Help Patients Struggling with Opioid Addiction

Wednesday, February 20

FDA: FDA Announces Availability of a Draft Guidance Titled Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry

Thursday, February 21

CDC: CDC Invites General Public and Federal Agencies Opportunity to Comment on Preventive Health and Health Services Block Grant Center for State, Tribal, Local and Territorial Support (CSTLTS)

Friday, February 22

CDC: CDC Submits Information Collection Request Titled Emerging Infections Program to the OMB

  • CDC Announces Availability of Information for Providers to Share with Male Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection

CMS: CMS Announces Opportunity for Public Comment on CMS’ Intention to Collect Information From the Public

FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on Continuing to Maintain Oversight of Generic Drug Quality Issues

  • Statement from FDA Commissioner Scott Gottlieb, M.D. on Brain-Computer Interface Devices to Help Patients with Paralysis or Amputation Gain Mobility

HHS: HHS Releases Final Title X Rule Detailing Family Planning Grant Program


UPCOMING EVENTS

SAMSA
Meeting: Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC) Meeting
February 27, 2019 9:00 AM – 5:00 PM
5600 Fishers Lane, Room 5N54, Rockville, MD

CDC
Meeting: Advisory Committee on Immunization Practices (ACIP)
February 27, 2019 8:00 AM – 5:30 PM & February 28, 2019 8:30 AM – 3:30 PM
CDC, 1600 Clifton Road, NE, Tom Harkin Global Communications Center, Building 19, Kent `Oz’ Nelson Auditorium, Atlanta, GA

NIH
Meeting: Helping to End Addiction Long-Term Multi-Disciplinary Working Group
March 4, 2019 8:30 AM – 5:00 PM
National Institutes of Health, Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892

FDA
Meeting: Enhancing the Incorporation of Patient Perspectives on Clinical Trials
March 18, 2019 9 AM – 5 PM
Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903

FDA
Meeting: Neurological Devices Panel of the Medical Devices Advisory Committee
March 21,2019 8 AM – 5 PM
Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877

NIH
Meeting: Office of AIDS Research Advisory Council
March 28, 2019 8:30 AM – 4:30 PM
National Institutes of Health, Conference Room 1D13, 5601 Fishers Lane, Rockville, MD 20892

CDC
Meeting: Clinical Laboratory Improvement Advisory Committee
April 11, 2019 8:30 AM – 1:00 PM
The Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244

NIH
Meeting: NIH Clinical Center Research Hospital Board
April 12, 2019 9:00 AM – 3:00 PM
National Institutes of Health, Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, National Institute of Mental Health
May 17, 2019 10:00 AM – 2:00 PM
National Institutes of Health, 1 Center Drive, Building 1, 3rd Floor, Wilson Hall, Bethesda, MD 20892

NIH
Meeting: National Advisory Council on Aging
May 21, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Building 60, Lecture Hall, One Cloister Court, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, National Institute of Mental Health
May 28-29, 2019 9:00 AM – 6:10 PM
National Institutes of Health, Porter Neuroscience Research Center, GE 620/630/640, Building 35A Convent Drive, Bethesda, MD 20892

NIH
Meeting: National Advisory Mental Health Council
May 30, 2019 9:00 AM – 1:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), Conference Rooms C/D/E, 6001 Executive Boulevard, Rockville, MD 20852

NIH
Meeting: National Advisory Mental Health Council
May 30, 2019 9:00 AM – 1:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), Conference Rooms C/D/E, 6001 Executive Boulevard, Rockville, MD 20852

NIH
Meeting: National Heart, Lung, and Blood Advisory Council
June 4, 2019 8:00 AM – 12:00 PM
National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892

HRSA
Meeting: Council on Graduate Medical Education
June 5, 2019  8:30 AM – 5:00 PM & June 6 8:30 AM – 2:00 PM
5600 Fishers Lane, Rockville, Maryland 20857

NIH
National Advisory Council on Aging
September 10-11, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), North Bethesda, 6001 Executive Boulevard, Rockville, MD 28052

NIH
Meeting: Center for Scientific Review
September 23, 2019 8:30 AM – 3:00 PM
National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, NIDDK
October 10-11, 2019 8:00 AM – 6:00 PM
National Institutes of Health, Building 10, Solarium Conference Room 9S233, 10 Center Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke
June 23-25, 2019 6:00 PM – 12:00 PM
Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814