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Latest Industry News

FDA

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up
Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle
FDA and industry reach agreement in principle on medical device user fees
Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans
FDA approves Kalydeco to treat rare form of cystic fibrosis
FDA takes action against New York cheese manufacturer
FDA approves new treatment for most common type of skin cancer
Treanda (bendamustine HCL): Recall - Particulate Matter in Vial
FDA approves Inlyta to treat patients with a type of advanced kidney cancer
Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Maine company holds cold smoked salmon product after FDA order
Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

Medical Devices

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up
Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle
Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets
Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans
Treanda (bendamustine HCL): Recall - Particulate Matter in Vial
Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

Press Releases

FDA and industry reach agreement in principle on medical device user fees
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
FDA approves Kalydeco to treat rare form of cystic fibrosis
FDA takes action against New York cheese manufacturer
FDA approves new treatment for most common type of skin cancer
FDA approves Inlyta to treat patients with a type of advanced kidney cancer
Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Maine company holds cold smoked salmon product after FDA order
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

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