USA – EPA proposes rules on EtO with implications for medical device sterilization

The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or...
New guidance on biologics affects authorized generics

USA – FDA: Nearly 700 breakthrough medical device designations since 2015

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...

USA – FDA proposes framework for human factors information in device submissions

The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...

USA – FDA revises final guidance on modifying remote monitoring devices

The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to...

USA – FDA finalizes two more safety and performance based pathway guidances

The US Food and Drug Administration (FDA) on Tuesday published two more final safety and performance based pathway guidances for medical devices on the...

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...

USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability

The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...

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The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

USA – FDA proposes updates to Breakthrough Devices Program guidance

The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its...

USA – FDA issues draft guidance on decentralized clinical trials

In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...

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