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
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
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
TGA Guidance: Submitting data in the eCTD format
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
UK MHRA: Guidance on International Recognition Procedure
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
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
Malaysia NPRA: Guidance on Drug Registration