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July 20, 2021

Always Tired? You May Have Sleep Apnea

Image The FDA is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due […]
July 20, 2021

Pharmacodynamic Biomarkers for Biosimilar Development and Approval – 09/20/2021 – 09/21/2021

On This Page Date: September 20 – 21, 2021 Day1: Mon, Sep 20 10:00 AM – 2:30 PM ET Day2: Tue, Sep 21 10:00 AM – […]
July 20, 2021

Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children

[embedded content] Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being […]
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 […]
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