Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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Regulations Marketing Clinical Trials Trials 40

Alta Sciences

MARCH 8, 2024

So much so that the HPAPI market is estimated to reach USD 31.5 billion by 2029. In each issue, they share their decades of knowledge to help sponsors along their early-phase drug development journeys, as well as explore the latest challenges and innovations in the industry. Tags Manufacturing and Analytical Services Weight 1

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Compliance Engineering Regulations Pharmaceuticals 52

Drug Discovery World

MAY 15, 2024

Marketed anti-VEGF therapeutics effectively neutralise retinal VEGF levels and reduce both vascular leak and consequential oedema, resulting in a temporary improvement in vision, but do nothing to address the underlying pathology – capillary drop-out 5. million by 2029, according to GlobalData. In 2019 there were >14.2

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Disease Treatment Therapies Pharmaceuticals 162

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA 40

FDA Regulations Laboratories Production 40

Drug Discovery World

JULY 26, 2024

While the shadow of the pandemic recedes, its effects linger in the form of a market correction and an evolving healthcare landscape. The Democrats’ Inflation Reduction Act (IRA) – particularly its Medicare drug price negotiation provision – is being touted as a win against ‘Big Pharma’s price gouging’.

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Science Government Biosimilars Marketing 130