by Pill Pals | Mar 18, 2025 | News
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-46 Product: Drugs Recipient: Recipient Name Mr. Stephen Saad Recipient Title Group Chief Executive Aspen Pharmacare Holdings Limited 9 Rydall Vale ParkDouglas Saunders Drive, La Lucia...
by Pill Pals | Mar 18, 2025 | News
For use by manufacturers to report biological product deviations (BPD) to the Food and Drug Administration that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also, for use by manufacturers of...
by Pill Pals | Mar 18, 2025 | News
Recipient: Recipient Name Laura E. Cohen, M.D. Recipient Title President CoLabs Intl. Corp 7251 W. Lake Mead Blvd Ste. 300Las Vegas, NV 89128United States info@klenskin.com Info@colabsintl.com Issuing Office: Center for Drug Evaluation and Research (CDER) United...
by Pill Pals | Mar 18, 2025 | News
CATT ProgramPurpose: The CATT was established to promote dialogue, education, and input among CBER staff and between CBER and innovators or developers of advanced manufacturing technologies. As part of these efforts, CBER provides an interactive opportunity for staff...
by Pill Pals | Mar 18, 2025 | News
Delivery Method: VIA Electronic Mail Reference #: 320-25-54 Product: Drugs Recipient: Recipient Name Mr. Ahmet Koyuncu Recipient Title CEO and Chairman of the Board of Directors Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi 14/1 Akcaburgaz Mahallesi, 137....
by Pill Pals | Mar 18, 2025 | News
Delivery Method: VIA Electronic Mail Reference #: CBER 25-696890 Product: Biologics Issuing Office: Center for Biologics Evaluation and Research (CBER) United States WARNING LETTERMarch 10, 2025 CBER 25-696890Dear Mr. Garcia:This is to advise you that the United...