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Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing

Alta Sciences

Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing pmjackson Fri, 03/08/2024 - 19:35 In recent years, advancements in oncological research have fueled a surge in demand for highly potent active pharmaceutical ingredients ( HPAPIs ). billion by 2029. Tags Manufacturing and Analytical Services Weight 1

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Diabetic eye disease: The urgent need for early, non-invasive treatments

Drug Discovery World

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. million diagnosed cases of diabetic retinopathy in the nine major pharmaceutical markets, expected to grow to >17.7 million by 2029, according to GlobalData. In 2019 there were >14.2

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

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.,

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

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.

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

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.,

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