Regulatory Blog

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