News - Pill Pals® - The Express Pharmacy

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CBER Rare Disease Program Frequently Asked Questions

by Pill Pals Customer Service | Jun 2, 2025 | News

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and caregivers, and listening to their perspectives on their diseases and treatments, may help us advance patient-focused medical product development. CBER’s...

Recalls (Biologics)

by Pill Pals Customer Service | Jun 2, 2025 | News

Image Recalls are a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recalls may be conducted on a firm’s own...

Over-the-Counter OTC | Nonprescription Drugs

by Pill Pals Customer Service | Jun 2, 2025 | News

On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is intended to increase options for the development and...

Increasing Predominance of Norovirus GII.17 over GII.4, United States, 2022–2025

by Pill Pals Customer Service | Jun 2, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA...

Ongoing | Vaccines

by Pill Pals Customer Service | May 30, 2025 | News

CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in...

Postmarketing Requirements and Commitments: Reports

by Pill Pals Customer Service | May 30, 2025 | News

Postmarketing Requirements and CommitmentsPostmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA. Under various statutory and regulatory authorities, FDA can require manufacturers of certain...