Alta Sciences

MARCH 8, 2024

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

Compliance 52

Compliance Engineering Regulations Drug Development 52

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.,

FDA 40

FDA Laboratories Regulations Production 40

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 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? That’s compared to the one we have now where a quarter of Americans struggle with drug prices.

Drugs 52

Drugs Government Vaccine Pharmaceuticals 52

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

Disease 64

Disease FDA FDA Approval Government 64

FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

The first sunset date is the authority to grant a priority review voucher to a rare pediatric disease product application for a drug that has not been designated as a drug for a rare pediatric disease. As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended.

Disease 59

Disease Government FDA Production 59