Michelle Eby Email & Phone Number

Review, triage, collaborate, manage, edit, verify, and clear responses to questions on postmarketing medication safety from the press, Congress and Staff, other government agencies including Center for Disease Control, Center for Medicare and Medicaid Services, and international regulatory agencies.Focal point and authoritative guidance for OSE personnel on Memoranda of Understanding (MOUs) with domestic and international stakeholders; manage speaking invitations, document clearance, and website development.Plan, coordinate, manage, and share information with international counterparts to advance theories and practices in post marketing surveillance and identify emerging problems and conflicts in post marketing safety to facilitate the assessment of risk and scientific decision making. Coordinate compliance with procedures, agreements, guidelines and policies. Office of Surveillance and Epidemiology lead for obtaining and sharing emerging information from international counterparts. Logistics lead for the 2017 Packaging and Abuse Deterrent Strategies Public Meeting, which helped contribute to three of the five pillars (i.e. Better Data, Better Pain Management and Better Research) of the Health and Human Services Departmental Strategy to combat the opioid crisis. Initiated, authored, managed and lead:• OSE Accomplishments Report for 2018 and 2019• OSE Annual Report for 2017• OSE Biweekly Report since June 2017 • OSE’s implementation of PDUFA VI and the 21st Century Cures Act. • OSE Commitment tracker for office’s goals; update to ensure consistency with current legislation• Office of Strategic Programs user fee activities, bi-monthly updates on PDUFA commitments for the Strategic Planning Team in OSP. • Lead project manager for OSE’s bi-weekly Strategic Implementation Steering Committee.

Silver Spring, Maryland, United States

Primary liaison to the Division of Urologic and Reproductive Products, the Division of Gastroenterology and Inborn Error Products, the Division of Dermatology and Dental Products, and the Rare Disease Program. Backup liaison for the Office of Hematology and Oncology Products, the Office of Translational Sciences, the Division of Nonprescription Drug Products, the Division of Pediatric and Maternal Health, the Office of Antimicrobial Drug Products, and the Office of Counterterrorism and Emergency Products. Liaison to the Pediatric and Maternal Health staff as well as the Office of Pediatric Therapeutics from 2012 to 2014. Documented development, analysis, and clearance of drug safety problems, and recommended courses of actions to resolve them. Developed timely responses to correspondence received from members of Congress, professional organizations, health care professionals, consumers, and others requesting technical and drug information from CDER. Evaluated new and proposed legislation and determine its potential impact on office and CDER Center activities, programs, industry, and consumers. Compiled Center comments and position papers on proposed legislation and high-level Center issues, including development of congressional testimony. Provided supportive information to Congress as part of the FDA budget process.Wrote project plans for the coordination and management of center-level projects. Drafted briefing documents for the Center Director, Commissioner, and Communication Timeline Meetings. Managed and drafted CDER Manuals of Policy and Procedures (MAPPs).