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July 20, 2021

Statins: Drug Safety Communication – FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy

[Posted 07/20/2021]  AUDIENCE: Patient, Health Professional, OBGYN, Cardiology, Endocrinology, Pharmacy    ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of […]
July 20, 2021

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

FDA reviewed data from case series and prospective and retrospective observational cohort studies over decades of use of statins in pregnant women.1-15 Multiple larger, well-designed, and […]
July 20, 2021

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil – 614402 – 07/08/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Selim Yesil Recipient Title Owner Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil N.12 Istanbul Endustri Ve Ticaret […]
July 19, 2021

Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference – 07/19/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration I am delighted to be with you to help kick […]
July 19, 2021

Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

Summary Company Announcement Date: July 16, 2021 FDA Publish Date: July 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above […]
July 19, 2021

Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines

Image By: Sandra Kweder, M.D., Deputy Director of the Europe Office, Office of Global Policy and Strategy; LCDR Shannon Thor, Pharm.D., Europe Office, Office of Global […]
July 16, 2021

FDA Approves New Use of Transplant Drug Based on Real-World Evidence

Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. […]
July 16, 2021

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

[7/02/2021] FDA is alerting patients and health care professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix), to […]
July 16, 2021

FDA approves belumosudil for chronic graft-versus-host disease

On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and […]
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