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
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
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022