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Bill to Let California Pharmacists Substitute Biosimilars

[ Price : $8.95]

California legislation would permit pharmacists to substitute generic biologics if they have been approved by FDA.

Judge Rules Against Preemption in Medtronic Suit

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An Arizona federal judge rejects Medtronics preemption arguments and is allowing continuation of a personal injury lawsuit that in...

JCB Labs Recalls 6 Product Lots Over Sterility Concern

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JCB Laboratories recalls six lots of sterile drug products due to sterility concerns after a recent FDA inspection cited problems ...

FDA Issues Clinical Investigator Review Guidance

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FDA publishes a guidance consolidating information on the role IRBs have in several aspects of clinical investigations.

FDA Posts June NADA, ANADA Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect June approval actions for NADAs and ANADAs.

Guidance on Reviewing Investigator Qualifications

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Federal Register Notice: FDA releases a guidance: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy...

Magellan Diagnostics Blood Lead Test Cleared

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FDA clears a Magellan Diagnostics 510(k) to market its LeadCare Ultra Blood Lead Testing System for use in quantifying lead levels...

FDA Moves to Public Shame on Late Pediatric Studies

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FDA begins posting letters to drug sponsors about their non-compliance with approval requirements pertaining to pediatric research...

FDA Approves Galderma Labs Mirvaso

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FDA approves a Galderma Laboratories NDA for Mirvaso (brimonidine) topical gel 0.33% for topically treating facial erythema in pat...

FDA Rejects Novartis Petition on Reclast Carve-out

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FDA denies a Novartis citizen petition that asked the agency to not approve any ANDA for a zoledronic acid IV (infusion) product b...