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Human Drugs

5 Former Insys Execs Convicted in Fentanyl Case

A federal jury in Boston convicts Insys Therapeuticss founder and four former executives on charges they bribed health professionals to prescribe Subs...

Human Drugs

Technical Comments on Food Effects Draft Guidance

Five stakeholders give FDA technical comments on a draft guidance on food effects on drugs.

Human Drugs

Trade Deals Dont Deliver on Drug Provisions: Analysis

Researchers say U.S. trade agreement containing protections sought by drug companies dont always provide benefits to Americans promised as part of the...

Human Drugs

FDA Posts REMS Changes Summary

FDA posts a summary of changes to 17 REMS made in March and April.

Human Drugs

Feds Join Questcor Whistleblower Case

Reuters reports the Justice Department is intervening in two whistleblower suits alleging that Questcor Pharmaceuticals illegally promoted its Acthar ...

Medical Devices

Lensar Laser System 510(k) Expands Corneal Use

FDA clears a Lensar 510(k) for the Lensar Laser System with Streamline IV to expand the platforms capabilities to include the creation of micro radial...

Human Drugs

Sagent Recalls Ketorolac Tromethamine Due to Sterility

Sagent Pharmaceuticals recalls one lot of ketorolac tromethamine injection due to lack of sterility assurance.

Medical Devices

FDA Wants Medical Device Patient Preference Feedback

FDA solicits feedback on its priority list of patient preference-sensitive areas intended to help the medical device industry and researchers.

Medical Devices

FDA OKs Medtronic CareLink SmartSync Device Manager

FDA approves Medtronics CareLink SmartSync device manager that works through an Apple iPad.

Corporate Compliance Guidance Tracks GMP: Attorney

Attorney Anne Walsh says a Justice Department guidance document on evaluating corporate compliance programs is similar to GMP requirements on drug and...