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Mesoblast Gets Fast Track for Remestemcel-L

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FDA grants Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome due to Covid...

AAM Says CRL Timeline Draft Guidance Raises Questions

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The Association for Accessible Medicines asks FDA to clarify several issues from a draft guidance on instances when a generic drug...

PhRMA Petitions to Stop Drug Import Program

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PhRMA uses a citizen petition to ask FDA and HHS to stop moving forward on their proposal to allow some drug importation from Cana...

Companies Ask Changes in Draft PBPK Guidance

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Four stakeholder companies raise questions about an FDA draft guidance on using physiologically based pharmacokinetic analyses in ...

AAMI Medical Device Remote Control Guidelines

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The Association for the Advancement of Medical Instrumentation publishes consensus guidelines for implementing remote control for ...

Info Collection for Nonclinical Good Lab Practices

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Federal Register notice: FDA sends to OMB an information collection extension for Good Laboratory Practice for Nonclinical Laborat...

Info Collection for eRecords/Signatures

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Federal Register notice: FDA sends to OMB an information collection extension for Electronic Records; Electronic Signatures 21 CF...

Comments on Unit-of-Use Blister Packaging for Opioids

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Federal Register notice: FDA reopens the comment period for a 5/31/2019 notice entitled Fixed-Quantity Unit-of-Use Blister Packagi...

Multiple Dietary Supplement Violations at ForYou

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FDA warns dietary supplement manufacturer ForYou, Inc., about CGMP and other violations in its production and distribution of diet...

MDIC Forms 5G Healthcare Technology Working Group

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The Medical Device Innovation Consortium says it has launched a stakeholder working group to address 5G-enabled healthcare technol...