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Abbott Insertable Cardiac Monitor Cleared

[ Price : $8.95]

FDA clears an Abbott 510(k) for its Assert-IQ insertable cardiac monitor for diagnosing and long-term monitoring of people experie...

Draeger Recalls Seattle CPAP Device and Components

[ Price : $8.95]

Draeger Medical recalls its Seattle PAP Plus continuous positive airway pressure device and VentStar breathing components due to b...

Draft Guide on Pediatric Drug Development

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Pediatric Drug Development Under the Pediatric Research Equity Act...

Pediatric Drug Exclusivity Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance on how to qualify for pediatric drug exclusivity.

Child Cancer Research Bill Reintroduced

[ Price : $8.95]

Reps. Eshoo and McCaul reintroduce the Give Kids a Chance Act to authorize FDA to direct drug companies to perform pediatric cance...

House Dems Working on Cancer Drug Shortage

[ Price : $8.95]

Rep. Frank Pallone praises FDA steps to reduce the shortage of the cancer drugs carboplatin and cisplatin.

FDA New Product-Specific Guidances

[ Price : $8.95]

FDA publishes 46 new or revised product-specific guidances to spur the development of generic drugs.

Appropriators Cut FDA Budget by $600 million

[ Price : $8.95]

A House Appropriations Subcommittee cuts FDAs fiscal year 2024 budget request by $600 million (8.3%).

Panel Backs Pfizers RSV Vaccine

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of a Pfizer BLA for its Abrysvo (RSVp...

2 Pediatric Drug Approval Guidances

[ Price : $8.95]

FDA publishes two guidances to assist in the development of drugs, biologics, and vaccines for pediatric use.