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8 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality new drug applications] ANDAs • Three-Year Exclusivity Determinations for Drug Products • Statistical Approaches to Establishing Bioequivalence • Evaluation of Therapeutic Equivalence. One anticipated update is FDA's implementation of the International Council for Harmonization Q12 guidance. Other updates include stability testing of drug products for ANDAs, inspection of injectable products, drug shortages, microbiological quality considerations in non-sterile drug product manufac- turing, and benefit/risk considerations. Guidances targeted to specific therapies include the following: • Chemistry Manufacturing and Controls Consid- erations for Individualize Antisense Oligonucle- otide (ASO) Therapies • Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations • Quality Considerations for Topical Ophthalmic Drug Products • PET Drugs–Current Good Manufacturing Prac- tice (CGMP); Revised Draft • Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross Contamination. Planned labeling documents includes guidance on labeling of biosimilars. The full list of upcom- ing labeling guidance documents is as follows: • Dose Banding: Considerations for Labeling • Immunogenicity Information in Human Prescrip- tion Therapeutic Protein and Select Drug Product Labeling—Content and Format • Labeling for Biosimilar Products (Revision 1) • Quantification of Sodium, Potassium, and Phos- phate in Human Over-the-Counter and Prescrip- tion Drug Labeling • Regulatory Considerations and Drug Labeling Recommendations for Prescription Drug Use-Re- lated Software for Combination Products • Statement of Identity and Strength—Content and Format of Labeling for Human Nonprescription Drug Products. For compounding pharmacies, the agency is planning the following five guidance documents: • Compounded Drug Products That Are Essen- tially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft • Compounded Drug Products That Are Essen- tially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft • Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Revised Draft • Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act • Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors–Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act. The agency also has more than 20 planned guid- ance documents regarding procedures for 2021. Top- ics include first interchangeable biological product, notifying the agency of manufacturing interruptions, use of real-world data, use of electronic records, and responding to Form 483s. CBER planned guidances The 2021 guidance agenda for CBER includes six documents for blood and blood components, seven documents on tissues and advanced therapies, and one guidance on CMC changes to approved ap-