WHITE HOUSE UPDATE

Opioids: Multi-Agency Partnership Launches $1.55 Million Dollar Global Prize Competition


LEGISLATIVE UPDATE

Tuesday, February 26

Hearing: Senate Finance Committee Chairman Chuck Grassley (R-IA) Statement from Hearing on Drug Pricing in America

  • Ranking Member Wyden’s Statement From Hearing on Drug Prices and Pharma CEOs

Drug Pricing: Senator Grassley’s Statement on Pharma Companies Lowering Prescription Drug Prices

  • Senator Grassley Discusses Drug Pricing on CNBC
  • Ranking Member Wyden Says Pharma Must Lower List Prices

DAV: Disabled American Veterans Express Concerns on Future Veterans’ Health Care

  • Senator Jon Tester (D-MT) and Senator Jerry Moran (R-KS) Introduce Legislation for Korean War Veterans
  • Senator Tester and American Legion National Commander Brett Reistad Express Concerns About the Impact on Veterans’ Health Care under the VA Mission Act
  • Committee on Veterans’ Affairs Chairman Mark Takano Gives Opening Remarks Before the Legislative Presentation of the DAV

HIV: Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) Sends Letter to HHS Requesting Briefing on Administration’s HIV Initiative

Wednesday, February 27

Health Care Costs: Energy and Commerce Chair Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) Announce Hearing on Bills to Make Health Care More Affordable and Accessible


REGULATORY UPDATE

Monday, February 25

CDC: Administrator of the World Trade Center Health Programs Announces Denial for Addition of a Health Condition to the WTC-Related Health Conditions List

FDA: FDA Announces Reopening the Comment Period for the Cures Act

  • FDA Announces Availability of Draft Guidance Entitled “Implanted Brain-Computer Interface Devices for Patients with Paralysis and Amputation
  • FDA Announces Availability of Additional Draft and Guidance on the Design of Bioequivalence Studies to Support ANDAs

Tuesday, February 26

FDA: FDA Announces Availability of Draft Guidance for Industry Entitled “Assessing the Effects of Food on Drugs in INDs and NDAs”

  • FDA Announces Reopening of Comment Period for the Notice “Prescription Drug-Use-Related Software; Establishment of a Docket”
  • FDA Commissioner Scott Gottlieb, M.D., and Director of the Center for Drug Evaluation Janet Woodcock, M.D. Statement on the Modern Approach to Advanced Pharmaceutical Manufacturing
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on the Policy and Regulatory Agenda Concerning the Opioid Epidemic

Wednesday, February 27

NIH: NIH Submits Request for Review and Approval for the Collection of Qualitative Feedback on Agency Service Delivery (NIAID)

CDC: CDC Data Confirms HIV Prevention has Stalled

Thursday, February 28

CMS: CMS and HHS Announce Extension of the Timeline for Publication of the Medicare, Medicaid, and Children’s Health Insurance Programs

  • CMS Announces Opportunity for Public Comment

FDA: FDA Posts Warning Letter to CanaRX for Selling Unapproved, Misbranded Drugs to Unsuspecting Americans

NIH: Data Sharing Uncovers New Risk Genes for Alzheimer’s Disease

Friday, March 1

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

FDA: FDA Provides Update on Investigation into ARB Drug Products


UPCOMING EVENTS

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

CMS
Meeting: Healthcare Common Procedure Coding System
May 13, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CMS
Meeting: Healthcare Common Procedure Coding System
May 14, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CMS
Meeting: Healthcare Common Procedure Coding System
May 15, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

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: 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