USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
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
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
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
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
Singapore's HSA: Regulatory Updates for Therapeutic Product Registration
Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission