by Pill Pals Customer Service | May 20, 2025 | News
Summary Company Announcement Date: May 15, 2025 FDA Publish Date: May 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared allergen – wheat. Company Name: Element 112, LLC dba Madeline’s Pâtisserie...
by Pill Pals Customer Service | May 20, 2025 | News
Delivery Method: VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED Reference #: CBER-24-654466 Product: Biologics Recipient: Recipient Name Christopher M.B. Sharp Recipient Title Chief Executive Officer Skye Biologics Holdings LLC 2255 Campus DrEl Segundo, CA...
by Pill Pals Customer Service | May 20, 2025 | News
Recipient: []Recipient Name []Salim Shah, PhD, JD []Recipient Title []Founder/President/CEO Sarfez Pharmaceuticals, Inc. []8000 Towers Crescent Drive Suite 1302Vienna, VA 22182United States Issuing Office: Center for Drug Evaluation and Research (CDER) []United States...
by Pill Pals Customer Service | May 20, 2025 | News
The Medical Device User Fee and Modernization Act (MDUFMA) requires the HHS Secretary to submit an annual report to Congress on the activities and impact of the Office of Combination Products (OCP). The report focuses on OCP’s efforts to ensure the prompt assignment...
by Pill Pals Customer Service | May 19, 2025 | News
Summary Company Announcement Date: May 18, 2025 FDA Publish Date: May 19, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: R&M Trading LLC Brand Name: Product Description: Company...
by Pill Pals Customer Service | May 17, 2025 | News
STN: 125817Proper Name: COVID-19 Vaccine, AdjuvantedTradename: NUVAXOVIDManufacturer: Novavax, Inc.Indication: NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome...
by Pill Pals Customer Service | May 16, 2025 | News
Summary Company Announcement Date: May 16, 2025 FDA Publish Date: May 16, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Allergen – Peanut Company Name: South Asian Foods Inc. Brand Name: Product...
by Pill Pals Customer Service | May 16, 2025 | News
Between April 25, 2017, and July 6, 2023, FDA identified 209 cases worldwide (197 domestic) of pruritus after stopping treatment with cetirizine (n=180), levocetirizine (n=27), or both (n=2), in the FDA Adverse Event Reporting System (FAERS) database. In all 209...
by Pill Pals Customer Service | May 16, 2025 | News
To locate a project or a qualified biomarker go to CDER & CBER’s DDT Qualification Project Search databaseWeb content is updated for consistency with 21st Century Cures Act!Get started with your submissionResources for Biomarker RequestorsMissionThe mission of...
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