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 ). So much so that the HPAPI market is estimated to reach USD 31.5

Compliance 52

Compliance Engineering Regulations Drug Development 52

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? The savings to the government would be about $345 billion between 2023-2029 because of lower prices.

Drugs 52

Drugs Government Vaccine Pharmaceuticals 52

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). 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

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. After 2024, the PDP sponsors will pay the enrollees’ 5% coinsurance during the catastrophic phase.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

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

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40