- FDA oversight of tobacco manufacturing establishments1
- FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments1
- Followup review: CMS's management of the quality payment program1
- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice1
- Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters1
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1
- HHS's Office of Refugee Resettlement improved coordination and outreach to promote the safety and well-being of unaccompanied alien children1
- Health care: telehealth and remote patient monitoring use in Medicare and selected federal programs : report to Congressional committees1
- Health document submission requirements for tobacco products: (revised)1
- Health information technology: HHS should assess the effectiveness of its efforts to enhance patient access to and use of electronic health information : report to Congressional requesters1
- Hospital value-based purchasing: CMS should take steps to ensure lower quality hospitals do not qualify for bonuses : report to Congressional committees1
- Human trafficking: investigations in Indian country or involving Native Americans and actions needed to better report on victims served : testimony before the Committee on Indian Affairs, U.S. Senate1
- IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards1
- Kentucky State Medicaid Fraud Control Unit: 2017 onsite review1
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff1
- Medicaid Fraud Control Units fiscal year 2016 annual report1