Home / Guidelines

Guidelines

Guidelines released on USAN naming

The American Medical Association (AMA) has issued guidelines on naming using United States Adopted Names (USAN), which are unique non-proprietary names assigned to pharmaceuticals sold in the US.

FDA opens pathway to biosimilar insulin products

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.

FDA to transition NDAs to BLAs

The US Food and Drug Administration (FDA) is soon to transition many new drug applications (NDAs) to biologicals license applications (BLAs), with significant implications for biotechnology companies and drug compounders.

Comments criticize FDA guidance on insulin biosimilars

Eli Lilly and Novo Nordisk have submitted critical comments on the US Food and Drug Administration’s (FDA) draft guidance on insulin biosimilars, which suggests that immunogenicity testing may not be necessary for all products.

FDA issues new rule on definition of term ‘biological product’

The US Food and Drug Administration (FDA) announced on 20 February 2020 that it had issued a final rule on the definition of the term ‘biological product’.

FDA issues new guidance for biosimilar user fees

The US Food and Drug Administration (FDA) has issued final guidance on the structure of the agency’s user fee programme under the Biosimilar User Fee Act of 2017 (BsUFA II).

FDA issues draft guidance on labelling and advertising of biologicals

The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

FDA issues draft guidance on licensing biosimilars for fewer indications

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.

UK medicines agency releases no-deal Brexit guidance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how to source comparator products for generic drug applications in the event of a no-deal Brexit.

FDA issues updated guidance on implementing GDUFA II

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).