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FDA proposes rule to collect antimicrobial sales and distribution data by animal species

The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain... read more

FDA releases draft guidance on animal drug compounding from bulk drug substances

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft ?Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk... read more

FDA approves spinal cord stimulation system that treats pain without tingling sensation

Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the... read more

FDA approves additional antibacterial treatment for plague

The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use... read more

Food and Drug Adminstration (FDA): CDRHNew

Posted Frequently Asked Questions about DBT and MQSA Training Requirements

Mammographic Modalities and MQSA Training Requirements. Q. Is digital breast tomosynthesis (DBT) a mammographic modality under MQSA? A. Under MQSA, there are currently not one, but three different DBT modalities.... read more

24 Hour Summary and Webcast Links posted for May 14-15, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting

24 Hour Summary and Webcast Links posted for May 14-15, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN130019 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN130019 added)

Slides Added to Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Draft Guidance - May 19, 2015

On May 6, 2015, FDA published a draft guidance, which provides a framework under which to consider extrapolating existing adult clinical medical device data to evaluate a device's performance in... read more

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Kogenate FS

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers

CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

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