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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.

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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

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Conference Connect: Determining the Future of Specialty Pharmacy

Pharmaceutical Commerce

“I really do think when we've got the patient at the center, we're all working together,” said Desi Kotis, PharmD, FASHP, chief pharmacy executive, UCSF Health. “ … Having all of us together, whether we need a social worker; the pharmacist; the advanced practice professional, the nurse practitioner or the physician assistant; the physician (..)

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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.

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

Pharmacy Times

In addition, pharmacy technicians conduct monthly refill adherence calls, and patients have the option for in-clinic assessments if needed. This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceutical manufacturers, medication access programs, and industry representatives.

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

Pharmacy Times

Author(s): Troy Trygstad, PharmD, PhD, MBA, Pharmacy Times Editor in Chief Yes. 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.

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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.