Guidelines

FDA issues post-CRL meeting guidance for generics makers

Home/Guidelines | Posted 07/12/2018

In December 2018, the US Food and Drug Administration (FDA) published a new guidance document to assist generics makers with meetings with the agency following the issuance of a complete response letter (CRL).

Chinese guidelines for copy biologicals

Home/Guidelines | Posted 21/11/2014

Last update: 30 November 2018

Since 2018, the China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA, 国家食品药品监督管理局) is the Chinese authority that oversees all drug manufacturing, trade, and registration [1].

Biosimilars makers in South Korea to benefit from new accounting guideline

Home/Guidelines | Posted 16/11/2018

South Korea’s financial authority has released new ‘relaxed’ guidelines for how drugmakers should list research and development ‘R & D’ spending as assets in an attempt to resolve the controversy that has haunted the market since early 2018.

FDA issues guidance for developers of complex generics

Home/Guidelines | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 9 October 2018 that it had released new guidance documents as part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines.

FDA to refer citizen petitions attempting to delay generics to FTC

Home/Guidelines | Posted 26/10/2018

The US Food and Drug Administration (FDA) announced on 2 October 2018 that it had released new draft guidance designed to limit the use of citizen petitions to delay approval of generics and biosimilars. The new guidance informs brand-name drugmakers how the agency would highlight any improper use of these petitions in its annual reports filed with Congress. It also highlights FDA’s intention to refer petitions that it judges as an attempt to delay competition to the Federal Trade Commission (FTC).

FDA releases new guidance to speed up generics approvals

Home/Guidelines | Posted 05/10/2018

The US Food and Drug Administration (FDA) has released a guidance document that aims to reduce the time that it takes for safe and effective generics to reach the market.

FDA releases product-specific guidance to increase generics competition

Home/Guidelines | Posted 21/09/2018

The US Food and Drug Administration (FDA) has issued 54 product-specific draft guidances with the aim of promoting access to generics and increasing drug price competition.

WHO asks for comments on new biosimilar Q&A

Home/Guidelines | Posted 14/09/2018

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

Home/Guidelines | Posted 31/08/2018

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

Home/Guidelines | Posted 24/08/2018

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

Home/Guidelines | Posted 20/07/2018

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

Home/Guidelines | Posted 06/07/2018

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

Home/Guidelines | Posted 29/06/2018

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

Home/Guidelines | Posted 15/06/2018

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

Global guidelines for biosimilars

Home/Guidelines | Posted 08/10/2010

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.