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
USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products
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
USFDA Guidance: Qualification of Medical Device Development Tools
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
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
Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain