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Patients Can Reduce Contact Lens Risk: CDC

[ Price : $8.95]

A CDC report calls for promotion activities to inform contact lens wearers of modifiable behaviors that can lead to corneal infect...

BioMerieux Offers UDI Guidance Clarifications

[ Price : $8.95]

bioMerieux recommends four changes to an FDA draft guidance on the form and content of unique device identifiers.

Companies Recalling More Kogenate/Helixate FS Lots

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FDA says Bayer has added eight more lots to the two lots of Kogenate FS being recalled due to potency declining faster than expect...

Guidance on Device Patient Preference Info

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Federal Register Notice: FDA releases a guidance on patient preference information for devices, which may inform FDAs benefit-risk...

Guidance on Fidaxomicin Bioequivalence Studies

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Federal Register Notice: FDA releases a draft guidance providing recommendations on the design of bioequivalence studies to suppor...

FDA Proposes to Expand Animal Drug Investigator Ineligibility

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Federal Register Proposed rule: FDA proposes to amend the regulations for new animal drugs for investigational use to expand the s...

FDA Proposes Quality System Approach to Nonclinical Lab Studies

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Federal Register Proposed rule: FDA proposes to amend good laboratory practice for nonclinical laboratory studies regulations to r...

FDA to Revise Categories for Animal Drugs in Feed

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Federal Register Proposed rule: FDA proposes to amend the animal drug regulations by revising the definitions of the two categorie...

SRS Seeking Expanded Use for Spanner Prostatic Stent

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SRS Medical Systems gains IDE approval to enroll patients in a study to expand the indications for use for its Spanner Temporary P...

Court Backs FDA Active Moiety Interpretation

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The DC federal court says FDA acted appropriately in approving Alkermes application for Aristrada before the expiration of three-y...