Alta Sciences

MARCH 8, 2024

So much so that the HPAPI market is estimated to reach USD 31.5 billion by 2029. Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects.

Compliance 52

Compliance Engineering Regulations Drug Development 52

Policy Prescription

MARCH 26, 2021

CBO looked at what would happen to the drug price market if elements of the Lower Drug Prices Now Act of 2019 (H.R. 3 contained policies to negotiate drug prices for Medicare. The savings to the government would be about $345 billion between 2023-2029 because of lower prices. 3) were implemented.

Drugs 52

Drugs Government Vaccine Pharmaceuticals 52

Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. This bill would extend the designation deadline until September 30, 2029, a five-year extension (and would require yet another GAO report).

Disease 64

Disease FDA FDA Approval Government 64

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