Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 51 of 54

52 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Resources: Guidelines T he following are some of the notable regulatory and standard setting resources, guidance documents, and guidelines. UNITED STATES The following are some key websites addressing regulatory requirements for biologics and other drug products*. • Vaccines, Blood, and Biologics • Guidance, Compliance, & Regulatory Information • FDA Guidance Documents • FDA Regulatory Science • FDA Compliance Actions and Activities • FDA Warning Letters Additional Resources • Federal Register • Federal Code of Regulations FDA Guidance Documents FDA's website provies a variety of regulatory resources including its list of current guidance documents. The following are some relevant guidance documents published in 2018 and 2019. Final Guidances • Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff • Population Pharmacokinetics • Considerations in Demonstrating Interchangeability with a Reference Product • Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations • REMS: FDA's Application of Statutory Factors in Determining When a REMS Is Necessary • Pediatric Information Incorporated into Human Prescription Drug and Biological Products Labeling Good Review Practice • Providing Regulatory Submissions in Electronic Format–Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications • Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection • Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway • Data Integrity and Compliance With Current Good Manufacturing Practice Resources, Guidelines, and Guidance Documents tashatuvango -

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