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
USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"