by Pill Pals Customer Service | Jun 3, 2025 | News
Recipient: Recipient Name Amy Lightner, MD Amy Lightner MD 604 Beardsley LaneAudtin, TX 78746United States amylightner8@gmail.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices Dear Dr. Lightner:The Food and...
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...
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...
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...
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...
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...
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