USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
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
Canada HC Guidance: Nitrosamine Impurities in Medications
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity