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WHO asks for comments on new biosimilar Q&A

As part of plans to provide additional clarification of its 2009 guidelines on the evaluation of biosimilars, the World Health Organization (WHO) has drafted a new document providing answers to questions that regulators have posed over the past eight years.

FDA issues final guidance on ANDA/PAS amendments

The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under Generic Drug User Fee Amendments II (GDUFA II).

FDA issues guidance for labelling biologicals and biosimilars

The US Food and Drug Administration (FDA) has issued two new guidance documents that provide recommendations to industry on labelling requirements for biologicals and biosimilars.

FDA issues final guidance on biosimilar user fees

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes introduced since BsUFA I.

FDA withdraws biosimilar statistical guidance

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended version that ‘will reflect state-of-the-art techniques in the evaluation of analytical data’ and give sponsors ‘appropriate flexibility’.

FDA issues draft guidance on biosimilar meetings

The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products.

FDA issues guidance on quality considerations for inhaled drugs

The US Food and Drug Administration (FDA) has issued draft guidance on quality considerations for inhaled drugs.

Global guidelines for biosimilars

Last update: 15 June 2018

The public health arm of the United Nations is World Health Organisation (WHO).

WHO, via its biological standardisation programme, develops guidelines and recommendations on the production and control of biological products and technologies.

FDA issues guidance on good manufacturing practice for APIs

The US Food and Drug Administration (FDA) has finalized revised guidance on good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).

FDA issues final guidance on bioanalytical method validation

On 21 May 2018, the US Food and Drug Administration issued final guidance on bioanalytical method validation.