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40 BioPharm International eBook March 2021 www.biopharminternational.com • T h r e e - Y e a r E x c l u s i v i t y Determinations for Drug Products • Statistical Approaches to Establishing Bioequivalence • E v a l u a t i o n o f T h e r a p e u t i c Equivalence • C o m p a r a t i v e A n a l y s e s a n d Related Comparative Use Human Factors Studies for a Drug Device Combination Product Submitted in an ANDA; Revised Draft. One anticipated update is FDA's i mpl e me nt at ion of I nte r n at ion a l C ou nc i l for Ha r mon i z at ion Q1 2 g u i d a n c e . O t h e r p l a n n e d t o p - ics include stabilit y testing of drug products for ANDAs, inspection of injectable products, drug shortages, microbiological quality considerations in non-sterile dr ug product manu- facturing, and benef it/risk consider- ations. Guidances targeted to specific therapies include the following: • C h e m i s t r y M a n u f a c t u r i n g a n d C o n t r o l s C o n s i d e r a t i o n s f o r I n d i v i d u a l i z e A n t i s e n s e Oligonucleotide (ASO) Therapies • D r u g P r o d u c t s A d m i n i s t e r e d V i a E n te ra l F e e d i ng Tu b e : In V i t r o Te s t i n g a n d L a b e l i n g Recommendations • Q u a l i t y C o n s i d e r a t i o n s f o r To p i c a l O p h t h a l m i c D r u g Products • P E T D r u g s - C u r r e n t G o o d Manufacturing Practice (CGMP); Revised Draft • N o n - P e n i c i l l i n B e t a - L a c t a m Drugs: A CGMP Framework for Preventing Cross Contamination. Planned labeling documents include guidance on labeling of biosimilars. The full list of upcoming labeling guidance documents is as follows: • Dose Banding: Considerations for Labeling • Immunoge nicit y Infor mation in Human Prescription Therapeutic Protein and Select Drug Product Labeling—Content and Format • Labeling for Biosimilar Products (Revision 1) • Q u a n t i f i c a t i o n o f S o d i u m , P o t a s s i u m , a n d P h o s p h a t e i n Hu m a n O v e r-th e - C o u nte r a n d Prescription Drug Labeling • R eg u l ato r y C on si d e rat ion s and Drug Labeling Recommendations f o r P r e s c r i p t i o n D r u g U s e - R e l a t e d S o f t w a r e f o r Combination Products • S t a t e m e n t o f I d e n t i t y a n d S t r e n g t h — C o n t e n t a n d For mat of L abeling for Human Nonprescription Drug Products. For compounding pharmacies, the agency is planning the following five guidance documents: • C o m p o u n d e d D r u g P r o d u c t s T h a t A re E sse nt i a lly C o p i es o f a Comme rcially Available D r ug P rodu ct Unde r Section 50 3 A of t h e F e d e ra l F o o d , D r u g , a n d Cosmetic Act; Revised Draft • C o m p o u n d e d D r u g P r o d u c t s T h a t A re E sse nt i a lly C o p i es o f Approved D r ug P roducts Unde r Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft • H o s p i t a l a n d H e a l t h S y s t e m Compounding Under the Federal Food , D r ug , and C osmetic Act ; Revised Draft • Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act • S a f e t y C o n s i d e r a t i o n s f o r C o n t a i n e r L a b e l s a n d C a r t o n L a b e l i n g D e s i g n t o M i n i m i z e Me d i c a t i o n E r ro r s – G u i d a n ce for Outsourcing Facilities Under Section 503B of the FD&C Act. T he agenc y a lso has more t han 2 0 pl a n ne d g u id a nc e d o c u me nt s r e g a r d i n g p r o c e d u r e s f o r 2 0 2 1 . Topics include f irst interchangeable biolog ic a l pro duc t , not i f y i n g t he agency of manufacturing interr up- tions, 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 applications. Some note- worthy guidance documents include the following: • Inte r p ret ing S am e ne ss o f G e n e T h e r a p y P r o d u c t s U n d e r t h e O r p h a n D r u g R e g u l a t i o n s ; Guidance for Industry • C o n s i d e r a t i o n s f o r t h e D e v e l o p m e n t o f H u m a n G e n e The rapy P roducts Incor porating Genome Editing; Draft Guidance for Industry • C o n s i d e r a t i o n s f o r t h e Development of Chimeric Antigen Receptor (CAR) T Cell Therapies; Draft Guidance for Industry. COVID-19 GUIDANCE The f irst quarter of 2021 saw the agency publish guidance on a variety of subjects, with treatments and prod- ucts to address COVID-19 receiving a good deal of the agency's attention. In March 2021, FDA published guid- ance providing recommendations for reporting and implementing changes to COVID-19 container closure sys- tem (CCS) components that consist of glass vials and stoppers for paren- teral sterile drug products and biologics (4). The guidance discusses regulatory approaches to CMC changes and com- mon changes to glass vials and stop- pers. The g uidance a lso discusses Regulatory Sourcebook Resources One anticipated update is FDA's implementation of International Council for Harmonization Q12 guidance.