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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

Report: FDA Meeting Review Goals Under PDUFA

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The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its [Read More...]

Tags: BLA Congress FDA GAO NDA PDUFA Priority REMS report Review Review Times Standard submission
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 | 28 March 2012

AIDS Group Calls for Hamburg’s Resignation

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The AIDS Healthcare Foundation (AHF) has launched an aggressive public advocacy campaign calling for the resignation of the US Food and Drug Administration’s top regulator, Commissioner Margaret [Read More...]

Tags: AHF AIDS Approval FDA Hamburg HIV NDA PrEP Resignation
Latest News | 28 March 2012

BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

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An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for [Read More...]

Tags: Approval Approved BIO Biologic BLA CRL drug FDA NDA Pharmaceutical Rate
Latest News | 19 March 2012

Health Canada Accelerating Approvals to Ease Drug Shortages

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Health Canada announced last week that it will expedite the review of 23 new drug applications (NDAs) in order to ease a growing shortage of medicines, reports Pharma Times.Federal Health Minister [Read More...]

Tags: Canada Drug Shortages Fire Health Canada NDA Review Sandoz
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 | 6 February 2012

FDA Releases New Draft Guidance on Positron Emission Tomography Products

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The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs. The guidance is intended to [Read More...]

Tags: ANDA Draft Guidance FDA NDA PET Positron Emission Tomography Q&A Questions and Answers
Latest News | 13 January 2012

CDER: Guidance on NDA/BLA/ANDA Data Standards Coming in Mid-2012

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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced on 12 January that it is planning to release new regulatory requirements by mid-2012 for electronic [Read More...]

Tags: 2012 ANDA BLA CDER Data Standards Program DSP FDA Guidance NDA