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New FDA guidance to speed up generics approvals

Updated guidance released by the US Food and Drug Administration (FDA) renews the criteria for receiving generic drug applications and downgrades certain deficiencies to ease the pressure on industry. 

FDA issues final guidance on naming biologicals

The US Food and Drug Administration (FDA) has issued final guidance detailing the agency’s requirements for the non-proprietary naming of biological products.

FDA issues draft guidance on biosimilar interchangeability

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals.

FDA issues final guidance on pharmacology data for biosimilarity

The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Biosimilars interchangeability guidance expected by end 2017

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

FDA issues final guidance on pharmacology labelling

The US Food and Drug Administration (FDA) on 2 December 2016 published final guidance for completing the clinical pharmacology section of labelling for human prescription drugs, which includes originator drugs, generics and biologicals.

FDA releases 67 new and revised bioequivalence guidelines for generics

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

FDA issues guidance on self-identification for generics makers

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

Regulations for biosimilars in South Korea

The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].

Naming requirements in Australian biosimilars guidance

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

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