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FDA issues 39 new and revised product-specific guidances

Posted 25 August 2021 | By Michael Mezher 

FDA issues 39 new and revised product-specific guidances

The US Food and Drug Administration (FDA) last week released its latest quarterly batch of product-specific guidances (PSGs), containing 23 new and 16 revised draft guidances.
 
"FDA publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate product development resources and prepare more complete submissions, especially for products that do not currently have approved generics," the agency wrote.
 
This latest batch of PSGs follows the release of two other batches of guidances in March and May of this year and brings the agency's running total of PSGs to 1,921. (RELATED: FDA issues 36 new and revised product-specific guidances, Regulatory Focus 25 March 2021; FDA releases batch of 21 product-specific guidances, Regulatory Focus 19 May 2021)
 
Some of the newly issued PSGs cover products used to treat human immunodeficiency virus (HIV), chronic obstructive pulmonary disease (COPD) and Cushing's disease.
 
FDA said that 28 of the guidances are for products with no approved generic competition, 15 of which are complex products.
 
In total, 22 of the PSGs, 11 new and 11 revised, apply to complex products. FDA said that several of these contain recommendations for in vitro bioequivalence studies to further facilitate generic development.
 
FDA also updated its list of upcoming PSGs for complex products the agency plans to issue within the next year, which currently contains more than 50 new PSGs and more than 80 revised guidances.
 
Among the new PSGs for complex products are guidances for generic versions of Boehringer Ingelheim's Atrovent (ipratropium bromide nasal spray) and two versions of the company's Respimat soft mist inhalers, Combivent Respimat (ipratropium bromide inhalation spray) and Striverdi Respimat (olodaterol hydrochloride inhalation spray). FDA said that generic drugmakers looking to develop the latter two can follow a similar development approach as laid out in its PSG for generic versions of Boehringer Ingelheim's Spiriva Handihaler (tiotropium bromide), which features "a weight-of-evidence approach to establish BE that consists of in vitro BE studies and a pharmacokinetic (PK) BE study. Notably, due to the unique device characteristics of the drug product, a comparative clinical endpoint or pharmacodynamic (PD) BE study is not recommended as part of the weight-of-evidence approach."
 
FDA also highlights its PSG for Novo Nordisk's type 2 diabetes drug Rybelsus (semaglutide), which offers two paths to establishing BE. "Depending on the generic applicant's proposed formulation, accounting for possible challenges in matching the formulation of the [reference listed drug]. Alternative study designs and approaches for a waiver of in vivo BE for lower strength(s) may be acceptable with proper justification," FDA wrote.
 
Federal Register notice

 

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