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Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to CDRHs...[ Price : $8.95]
FDA clears an Avinger 510(k) for the Pantheris Lumivascular atherectomy system for use in Peripheral Artery Disease patients for t...[ Price : $8.95]
Former FDAer Peter Pitts says that drug companies have information that could improve patients health and FDA should find ways to ...[ Price : $8.95]
An FDA-483 details inspection observations from Akorn Pharmaceuticals.[ Price : $8.95]
CDER Office of New Drugs director John Jenkins publicly criticizes last months controversial decision of his boss, Center director...[ Price : $8.95]
Attorney James Beck praises an appeals court decision that a plaintiff law firm does not have standing to sue FDA to compel the ag...[ Price : $8.95]
Five stakeholder groups offer praise and suggestions to improve an FDA draft guidance on use of public databases to support clinic...[ Price : $8.95]
The 9th Circuit appeals court upholds a lower court decision that Physicians for Integrity in Medical Research has no standing to ...