Global Pharma Guidance Tracker – May 2021
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On
Amphastar will not be receiving approval in 2022 for its proposed generic version of Eli Lilly’s Forteo (teriparatide) peptide for the treatment of osteoporosis, after the FDA told the company it could not issue an approval at this stage.
EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.