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Latest News | 21 May 2012

FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

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The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national [Read More...]

Tags: ANDA drug FDA FDA Form 2657 National Drug Code NDA NDC Pharmaceutical
Latest News | 1 May 2012

CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal [Read More...]

Tags: ANDA ANDAs Appeal Expedited Review Request Extraordinary Hardship FDA MAPP OGD Staff Supplement
Latest News | 19 April 2012

Owe FDA Money? Don’t Bother Submitting an Application, Says CDER

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A new Manual of Policies and Procedures (MAPP) document issued by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) notes that if a pharmaceutical manufacturer [Read More...]

Tags: ANDA Application Arrears CDER debt FDA MAPP Money NDA Owed submission User Fee User Fees
Latest News | 12 April 2012

FDA Presentation Highlights Dramatic Need for GDUFA Legislation

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An official from the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Science (OPS) provided a presentation on the state of the proposed Generic Drug User Fee Act (GDUFA), which [Read More...]

Tags: ANDA drug GDUFA Generic OPS Pharmaceutical User Fee Wesdyk
Latest News | 27 March 2012

New Draft Guidance on Bioequivalence Recommendations for Iron Sucrose Injection

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The US Food and Drug Administration (FDA) released new draft guidance for industry on 27 March entitled Bioequivalence (BE) Recommendations for Iron Sucrose. The guidance instructs industry how to [Read More...]

Tags: ANDA Anemia BE Bioequivalence Draft drug FDA Guidance Iron Pharmaceutical
Latest News | 14 March 2012

FDA Approves Generic Lexapro

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The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety [Read More...]

Tags: 180-Day ANDA Antidepressant Exclusivity FDA Forest Generic Lexapro Teva
Latest News | 9 March 2012

Petitions to Delay Generic Seroquel Denied

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Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration [Read More...]

Tags: ANDA Antipsychotic AstraZeneca CDER Citizen Petition Denial Denied FDA Petition RLD Seroquel Seroquel XR Woodcock
Latest News | 28 February 2012

FDA Releases Guidance on Proper Size, Testing of Sprinkled Drug Products

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The US Food and Drug Administration (FDA) released guidance 29 February that provides the agency’s current thinking about the proper size ranges and testing methods for drug products that are [Read More...]

Tags: ANDA Beads BLA FDA Guidance NDA Sprinkle Sprinkled Testing
Latest News | 13 February 2012

Draft Guidance for Nitroglycerin, Rifaximin Products Released by FDA

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The US Food and Drug Administration (FDA) released new draft guidance documents on 13 February covering rifaximin tablets, nitroglycerin metered spray/sublingual products and nitroglycerin metered [Read More...]

Tags: ANDA BE Bioequivalence Draft Guidance FDA Nitroglycerin Rifaximin
Latest News | 13 February 2012

Reps. Waxman, Rush Introduce Bill to Stop 'Pay-For-Delay' Settlements

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A bill introduced by Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) on 9 February would end so-called “pay-for-delay” settlements used by pharmaceutical companies to delay competition from [Read More...]

Tags: 180-Day Exclusivity ANDA Bill Congress Generic Pay For Delay Pay-For-Delay Rush Settlement Waxman
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