FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program

7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program.  ...

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FDA aims to expand early approval program for promising drugs

30 November 2017 - Scott Gottlieb speaks before House subcommittee on health. ...

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FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action

15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer ...

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FDA improves access to reports of adverse drug reactions

28 September 2017 - New online tool makes it easier for users to search the FDA Adverse Event Reporting System. ...

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New FDA pathway to accelerate development of cell therapies

22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with ...

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FDA and NIH release final template for clinical trial protocols

2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...

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'Burdensome' FDA drug approval process fuels innovation, saves lives

28 February 2017 - I watched two speeches today that shared a common drug topic but with opposing philosophies.  ...

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Trump derides ‘slow and burdensome’ approval process at FDA

28 February 2017 - President Trump on Tuesday called on the FDA to speed the approval of drugs to treat ...

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Grassley launches inquiry into orphan drugs after KHN investigation

10 February 2017 - Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential ...

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Statement from FDA Commissioner Robert Califf on the release of the final individual patient expanded access form

2 June 2016 - Today, the U.S. FDA finalized its efforts to streamline the process used by physicians to request expanded ...

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