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Pacira Disputes FDA Warning on Exparel Promotions

[ Price : $8.95]

Pacira says it believes that, contrary to an FDA Warning Letter, its Exparel promotional materials are consistent with the current...

Rexahn Pancreatic Cancer Drug Gets Orphan Status

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FDA grants orphan drug designation to a Rexahn experimental pancreatic cancer drug.

FDA Orders Seizure of Kratom from California Company

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U.S. marshals seize more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management (Van Nuys,...

Generic Competitor for BioMarins Kuvan Notifies FDA

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BioMarin Pharmaceutical reports that FDA has received a Paragraph IV certification notice letter about an ANDA for a generic versi...

Comments Sought on Veterinary Feed Directive Reporting

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Federal Register Notice: FDA seeks comments on reporting and recordkeeping requirements for use of Veterinary Feed Directive drugs...

Guidance on Fluoroscopic Equipment Requirements

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Federal Register Notice: FDA releases a draft guidance: Policy Clarification for Fluoroscopic Equipment Requirements.

FDA Publishes Approved PMA List

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

Ala. Court Decision Raises Many Questions: Attorney

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Attorney Bert Rein calls for a new pharmaceutical product liability regime nationally to eliminate the inadequacies and inequities...

Baxter, Merrimack Form Pact on Pancreatic Cancer Therapy

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Baxter International and Merrimack Pharmaceuticals enter into a licensing and development agreement for nanoliposomal irinotecan, ...

Clarification Sought in Informed Consent Guidance

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Commenters suggest ways to improve an FDA draft informed consent information sheet guidance.