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FDA Clears Dx 360 Rotatable Disposable Sheath

[ Price : $8.95]

FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hyste...

Recommendations for Neonatal Pharmacology Guidance

[ Price : $8.95]

Four stakeholders praise and recommend changes to an FDA draft guidance on general clinical pharmacology considerations for neonat...

CDER Office of Hematology, Oncology Products Reorganized

[ Price : $8.95]

CDER has completed reorganization of the Office of Hematology and Oncology Products into the Office of Oncologic Diseases.

Safety Surveillance Best Practices Draft

[ Price : $8.95]

FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs ...

Senate Sets 11/20 FDA Confirmation Hearing

[ Price : $8.95]

The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Step...

Sandoz Neulasta Biosimilar Approved

[ Price : $8.95]

FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).

Expanded Field-of-View Laparoscope Cleared

[ Price : $8.95]

FDA clears a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera sy...

Put Tramadol in High CSA Classification: Public Citizen

[ Price : $8.95]

Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to ...

CBER Regulatory Meeting SOPP

[ Price : $8.95]

CBER issues a SOPP on regulatory meetings under some user fee programs.

GSK Asks FDA Review of Zofran Information

[ Price : $8.95]

GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy label...