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 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
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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
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022
USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
USFDA Guidance: Qualification of Medical Device Development Tools