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December 22, 2021

FDA approves add-on therapy to lower cholesterol among certain high-risk adults

Action FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial […]
December 22, 2021

Approvals & Reports

The Office of Generic Drugs publishes a list of first-time approvals to manufacture generic drugs and a variety of reports on generic drug application activities to […]
December 22, 2021

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

For Immediate Release: December 22, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir […]
December 22, 2021

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Submit Comments by 03/22/2022 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 […]
December 21, 2021

Fighting Diabetes’ Deadly Impact on Minorities

Español You inherit more than your eye and hair color from your family. You can also inherit a predisposition for diabetes, a disease that disproportionally affects […]
December 21, 2021

Lock it Up: Medicine Safety in Your Home

[embedded content] Every year thousands of children are hospitalized—and some die—after taking medicine not meant for them. Teens share stolen prescription drugs at “pharm parties” and […]
December 21, 2021

Maquiladora Miniara SA de CV – 609152 – 12/15/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Anuar Farah Said Recipient Title Managing Director Maquiladora Miniara SA de CV Carretera Teoloyucan HuehuetocaKm. 22 […]
December 21, 2021

Guangdong Kemei Pharmaceutical Technology Co. Ltd. – 612090 – 12/14/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jack Chen Recipient Title CEO Guangdong Kemei Pharmaceutical Technology Co. Ltd. 2,4, No.16 (#6 Plant), Jiye […]
December 21, 2021

Wholly Liquid Nutritional Supplements LLC – 617324 – 12/09/2021

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Dr. Douglas A. Wine Recipient Title Registered Agent Wholly Liquid Nutritional Supplements LLC 5R […]
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