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April 5, 2022

Little Difference in Child Growth After Assisted Reproduction Little Difference in Child Growth After Assisted Reproduction

The study covered in this summary was published in medRxiv as a preprint and has not yet been peer reviewed. Key Takeaways A meta-analysis of 25 […]
April 5, 2022

NDAL Mfg Inc. – 621656 – 03/28/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Gavin Gear Recipient Title CEO NDAL Mfg Inc. 80 Garden Court, Suite 100Monterey, CA 93940United States […]
April 5, 2022

Honey Feast, Inc. – 621651 – 03/17/2022

Delivery Method: Via Email Product: DrugsFood & Beverages Recipient: Recipient Name Charles E. Sanford Recipient Title Owner Honey Feast, Inc. 6906 Lake Nellie Rd.Clermont, FL 34714-8368United […]
April 5, 2022

The ABCs of Product Specific Guidances

What are PSGs:Product-specific guidances (or PSGs for short) describe the Agency’s current thinking on the evidence needed to demonstrate that a generic drug is therapeutically equivalent […]
April 5, 2022

Early PCSK9 Inhibition in AMI Yields Plaque Regression Early PCSK9 Inhibition in AMI Yields Plaque Regression

When the PCSK9 inhibitor alirocumab is added to high-intensity statins soon after an acute myocardial infarction (AMI), the reduction in atheroma volume is doubled at 12 […]
April 5, 2022

CDER Quality Management Maturity

What’s New 04/05/22 CDER’s Office of Pharmaceutical Quality (OPQ) released a whitepaper on Quality Management Maturity (QMM). To increase transparency and incentivize investment in mature quality […]
April 5, 2022

Ukraine War Likely to Cause Infection Outbreaks Ukraine War Likely to Cause Infection Outbreaks

Every day we see stark images of the war in Ukraine — bombed-out buildings, explosions, and bodies lying in the streets. But there’s another, less visible […]
April 4, 2022

FDA Approves Leadless, Single-Chamber Pacemaker System FDA Approves Leadless, Single-Chamber Pacemaker System

The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia. In a press release, Abbott said the device […]
April 4, 2022

Urologic Scopes Recalled Over Contamination Fears Urologic Scopes Recalled Over Contamination Fears

Karl Storz is recalling more than two dozen models of its urological endoscopes over concerns that the devices may not be adequately cleaned using instructions from […]
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