USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms

The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...

USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules

Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...

USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products

The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...

USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...

USA – FDA updates guidances to reflect new MDUFA goals

The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under...
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Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request

The European Commission has released a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards it will...

USA – FDA drafts guidance on medical device voluntary improvement program

The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP)...

USA – FDA asks manufacturers to develop risk management plans to avert shortages

The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...

USA – MDUFA V: US FDA sets performance goals for De Novo medical device...

The US Food and Drug Administration (FDA) has issued a commitment letter describing draft amendments to its medical device review procedures. The agency is...

USA – FDA eases labeling, clarifies IVD requirements in COVID transition guidances

The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to...

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