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Info Collection Extension on Animal Drug Index

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Index of Legally Marketed Unapproved New An...

Expedited Development, Approval in 60% of Novel Drugs

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A CDER report on 2019 novel drug approvals shows that 60% of the 48 drugs approved came under at least one expedited development a...

BioMarin Wants Better CDER/Sponsor Communications

[ Price : $8.95]

Stakeholders look for ways to improve meaningful communication between the Office of New Drugs and stakeholders involved in drug d...

CBER Approved Gene Therapy, 3 Vaccines in 2019

[ Price : $8.95]

The FY 2019 report issued by CBER director Peter Marks touts several different types of drug and vaccine approvals.

IceCure Medical Cleared for Cryoablation Tech

[ Price : $8.95]

FDA clears an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezin...

Abbott Gets Approval for HeartMate 3 Surgical Technique

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FDA approves Abbotts new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure...

FDA Meeting on Data Strategy Modernization

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FDA schedules a 3/27 public meeting on modernization of the agencys data strategy.

Emery Pharma Wants Zantac Recalled and Sales Suspended

[ Price : $8.95]

Emery Pharma calls on FDA to take multiple steps to control ranitidine products that can develop NDMA when exposed to high tempera...

Changes Sought in Draft IND Safety Report Guidance

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Stakeholders raise questions on an FDA draft guidance on submitting IND safety reports in electronic format to FAERS.

Teva Paying $54 Million to Settle Whistleblower Suit

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Teva agrees to pay $54 million to settle a whistleblower suit alleging that it used sham speaker and consulting programs to reward...