Policy Prescription

MARCH 26, 2021

Would you vote for legislation to lower drug prices that would lead to a five percent reduction in pharmaceutical innovation — yet simultaneously create a health system in which all Americans could afford the prescription drugs they need? His conclusion is that we can start by allowing Medicare to negotiate drug prices. “We

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Drugs Government Vaccine Pharmaceuticals 52

Alta Sciences

MARCH 8, 2024

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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Compliance Engineering Regulations Drug Development 52

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.,

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Compliance Drugs Pharmacy Licensing 105

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). billion by 2029. By geographical region, the global CRO services market in 2023 was dominated by North America. As a result, the global CRO market is estimated to grow at a compound annual growth rate (CAGR) of 9.6%

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

JANUARY 26, 2024

MDR Article 78(14) sets out the original transition deadline in going from voluntary use of the coordinated assessment process to mandatory use as May 25, 2027; for IVDs, use of the coordinated procedure becomes mandatory in May 26, 2029 for all Member States, as set out in IVDR Article 74(14). Once the E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

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FDA Laboratories Regulations Production 40