Ethics/Regulatory

FDA seeks $4.5 billion FY 2013 budget

Tuesday, February 14, 2012 11:56 AM

The FDA is requesting a budget of $4.5 billion to protect and promote the public health as part of the president’s fiscal year 2013 budget—a 17% increase over the FDA enacted budget for FY 2012.

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FDA issues draft guidance on biosimilar product development

Thursday, February 9, 2012 01:58 PM

The FDA has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the U.S.

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European Commission and Mario Monti seek to increase patient access to generic medicines

Wednesday, February 8, 2012 10:06 AM

The European Generic Medicines Association (EGA) and Assogenerici, the Italian association for generic medicines, welcome the European Commission’s formal call on Italy to comply with European Union rules on the marketing authorization of generic medicines.

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NICE refuses to recommend Janssen’s Zytiga for prostate cancer

Wednesday, February 8, 2012 09:58 AM

The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.

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New bipartisan legislation to address prescription drug shortages

Monday, February 6, 2012 01:58 PM

U.S. Representatives John Carney (D-Del.) and Larry Bucshon (R-Ind.) introduced the Drug Shortage Prevention Act Jan. 31, which addresses the scarcity of certain pharmaceutical drugs in the marketplace.

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Pew Health urges Congress to reauthorize PDUFA

Monday, February 6, 2012 08:38 AM

Allan Coukell, director of medical programs at the Pew Health Group, issued a statement concerning a U.S. House energy and commerce subcommittee on health hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), which has shortened the pharmaceutical approval process by the FDA.

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FDA approves Erivedge to treat skin cancer

Monday, January 30, 2012 04:02 PM

Genentech’s Erivedge (vismodegib) has been approved by the FDA to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

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FDA’s CDRH sets goals for personalized medicine

Tuesday, January 24, 2012 02:51 PM

The FDA's Center for Devices and Radiological Health has set personalized medicine as one of its priorities for the current year, aiming for draft guidance on co-development of drugs and diagnostics by year's end.

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FDA includes social media in advertising guidance

Tuesday, January 24, 2012 02:45 PM

The FDA has issued a final guidance for industry product name placement, size and prominence in advertising and promotional labeling, including juxtaposition of proprietary and established product names.

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FDA approves label change for Tysabri

Tuesday, January 24, 2012 10:48 AM

The FDA has approved a product label change for Biogen Idec/Elan’s Tysabri that will help enable individual benefit-risk assessment for patients with multiple sclerosis (MS).

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