USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
USFDA Guidance: Premarket Notification [510(k)] Submissions
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products