CARVYKTI

by Pill Pals Customer Service | Jun 26, 2025 | News

STN:125746 Proper Name: ciltacabtagene autoleucelTradename: CARVYKTIManufacturer: Janssen Biotech, Inc.Indications: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome...

Cybersecurity: Quality System Considerations and Premarket Submissions

by Pill Pals Customer Service | Jun 26, 2025 | News

Docket Number: FDA-2021-D-1158 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the...

Unique Device Identifier Requirements for Combination Products

by Pill Pals Customer Service | Jun 26, 2025 | News

Submit Comments by 09/24/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

mRNA COVID-19 Vaccines: FDA Safety Communication

by Pill Pals Customer Service | Jun 26, 2025 | News

AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, CardiologyISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA)...

Guidance for Industry

by Pill Pals Customer Service | Jun 26, 2025 | News

Docket Number: FDA-2013-D-0744 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Antibacterial...

LEC Custom Products, Inc. – 607838

by Pill Pals Customer Service | Jun 26, 2025 | News

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jeremy Willard Recipient Title President & CEO LEC Custom Products, Inc. 7 Kenview BoulevardBrampton ON L6T 5G5Canada Via UPS Issuing Office: Center for Drug Evaluation and Research | CDER...