WARNING LETTER UPS NEXT DAY SIGNATURE REQUIRED September 7, 2018                                                                                                                                                                                                                              WL # 553572 Mr. David D. Blanco, President The Delano Company, […]

The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints Clinical endpoints are measurable events or outcomes that can help determine whether a medical intervention, […]

FDA Research Focused on Direct-to-Consumer Television Advertising Clinical endpoints are measurable events or outcomes that can help determine whether a medical intervention, such as a therapy, […]

WARNING LETTER Jan 8, 2019 VIA UNITED PARCEL SERVICE Ref:#19-HFD-45-01-01 Lymol Medical Corporation Attention: Kim Abrano, Chairman & CEO 4 Plympton Street Woburn, MA 01801 Dear […]

Product: Drugs Recipient: Recipient Name Mr. Hak-Ki Kim Recipient Title President Barox Co., Ltd. Number 706, HallaSigma, 545, Dunchon-DaeroJungwon-gu, Gyeonggi-doSeongnam13215South Korea Issuing Office: Center for Drug […]

Action FDA has approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or […]

Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) Good morning. I’m I pleased to have this opportunity to speak with you again. […]

Submit Comments by 08/17/2023 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 […]

Submit Comments by 08/17/2023 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 […]