FDA issues final guidance on petitions delaying generics

Home/Guidelines | Posted 08/11/2019

The US Food and Drug Administration (FDA) announced on 18 September 2019 that it had issued final guidance to address ‘gaming’ by the use of citizen petitions.

US guidelines for biosimilars

Home/Guidelines | Posted 12/11/2010

Last update: 25 October 2019

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

FDA planning more guidance for developers of complex generics

Home/Guidelines | Posted 18/10/2019

As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.

EMA provides guidance on avoiding nitrosamines in human medicines

Home/Guidelines | Posted 11/10/2019

On 26 September 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided guidance on avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesized active substances, following a request from EMA’s Executive Director. 

FDA organizes workshop on complex generics

Home/Guidelines | Posted 13/09/2019

The US Food and Drug Administration (FDA) has announced that the agency is organizing a workshop on the regulation of complex generics.

Comments on FDA’s plans to transition insulin products

Home/Guidelines | Posted 14/06/2019

The US Food and Drug Administration (FDA) held a public meeting on the 13 May 2019 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.

FDA issues guidance on quality-related considerations for biosimilars

Home/Guidelines | Posted 31/05/2019

The US Food and Drug Administration (FDA) has issued draft biosimilar guidance on quality-related considerations.

The draft guidance was published in a Federal Register announcement published on 22 May 2019. It aims to assist biosimilars developers on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

Stakeholders question FDA’s guidance on naming biologicals

Home/Guidelines | Posted 24/05/2019

In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1]. Many stakeholders comments on the document call for a change in policy from the agency when it comes to naming biologicals.

FDA issues final guidance on interchangeable biologicals

Home/Guidelines | Posted 17/05/2019

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

FDA pledges to improve quality of compounded drugs

Home/Guidelines | Posted 10/05/2019

The US Food and Drug Administration (FDA) released a statement on 3 April 2019 detailing its priorities for improving the quality of compounded drugs in 2019.