article thumbnail

USP announces new Advanced Technologies Laboratory to accelerate and scale pharmaceutical manufacturing innovations

Pharmacy Times

The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.

article thumbnail

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Pharmacy Policy Updates for June 2025

Pharmacy Times

3,4 How this pricing model will be implemented and whether pharmaceutical manufacturers will be able to meet the expectations of the 2025 executive order, if upheld, is uncertain. The order states that if manufacturers are unable to meet the 30-day deadline, the secretary of the Department of Health and Human Services, Robert F.

article thumbnail

Specialty Pharmacist Integration in Neurology Clinics: A Model for Enhanced Patient Care

Pharmacy Times

This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceutical manufacturers, medication access programs, and industry representatives. In many cases, the pharmacist resolves the issue independently, escalating to the provider only when necessary.

article thumbnail

Do We Really Pay More for Prescription Drugs in the United States?

Pharmacy Times

5 The Most Significant Driver of Health Care Spend Isn’t Drugs—It Isn’t Even Close Pharmaceutical manufacturers are a frequent punching bag for politicians, mostly because they are easy targets, and they tend to have more visible out-of-pocket exposure.

article thumbnail

Examining the One Big Beautiful Bill Act on Prescription Drugs: Benefits and Criticisms

Pharmacy Times

4 TAX INCENTIVES FOR PHARMA AND RESEARCH AND DEVELOPMENT The OBBB extends and amplifies existing tax breaks, including research and development (R&D) credits and incentives for onshoring manufacturing—measures favored by pharmaceutical manufacturers.

article thumbnail

Florida’s Prescription Drug Reform Act: What it Means for Florida Pharmacies

Digital Pharmacist

The Prescription Drug Reform Act aims to regulate pharmacy benefit managers (PBMs) and pharmaceutical manufacturers in the state. The primary focus of this act is to bring transparency, accountability, and fairness to the outpatient pharmaceutical system in Florida, especially in relation to PBMs.