Titles
- Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff1
- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- Compliance policy for limited modifications to certain marketed tobacco products1
- Concerns about opioid use in Medicare Part D in the Appalachian region1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- Considerations for the development of dried plasma products intended for transfusion1
- Considerations for the inclusion of adolescent patients in adult oncology clinical trials1
- Considerations in demonstrating interchangeability with a reference product1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Defense health care: opportunities to improve future TRICARE managed care support contract transitions : report to Congressional committees1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Drug control: the Office of National Drug Control Policy should develop key planning elements to meet statutory requirements : report to Congressional addressees1
- Drug safety: preliminary findings indicate persistent challenges with FDA foreign inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1
- Effects of the Patient Protection and Affordable Care Act on coverage and access to care in metropolitan vs. non-metropolitan areas through 20161
- Electronic capabilities for patient engagement among U.S. non-federal acute care hospitals: 2013-20171
- Electronic prescribing of controlled substances among Medicare Part D prescribers: 2015-20161
- Electronic prescribing of controlled substances among office-based physicians: 20171
- Employment of people ages 55 to 791