Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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Agency IQ

MAY 31, 2024

There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). s Medicines and Healthcare products Regulatory Agency (MHRA).

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Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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Agency IQ

MARCH 1, 2024

European Parliament negotiations on the proposed regulation and directive to overhaul the pharmaceutical legislation are ongoing. Although our POLITICO Pro EU colleagues have provided some updates, the discussions are held behind closed doors.

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Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. There will also be a rescheduled webinar held at the end of the month to go over the Artificial Intelligence Airlock initiative spearheaded by the U.K.’s ’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

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