News

Latest News | 13 May 2013

In Shift, FDA Denies Endo Petition to Ban Generic Painkiller, Slamming Citizen Petition's Use of Data

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In a surprising move, the US Food and Drug Administration (FDA) on 10 May 2013 announced that it would permit generic competition to Endo Pharmaceuticals' generic pain pill Opana ER (oxymorphone Read More...

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Latest News | 15 April 2013

Now-Withdrawn Antidepressant's Bioequivalency Problems Raises Unanswered Issues, FDA Says

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The US Food and Drug Administration (FDA) is looking to sponsor its own bioequivalency studies on more generic versions of a popular antidepressant in the wake of the agency's October 2012 finding Read More...

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Latest News | 13 March 2013

Citing Differences, FDA Generics Director Greg Geba to Resign

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The US Food and Drug Administration's (FDA) Director of the Office of Generic Drugs (OGD), Greg Geba, will resign effective 15 March 2013 over disagreements regarding his vision for the office, the Read More...

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Latest News | 27 February 2013

China's SFDA Announces Major Reforms to Drug Regulatory Process

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China’s State Food and Drug Administration (SFDA) has announced that it is implementing a series of reforms designed to improve the drug review and approval process, “and to promote the healthy Read More...

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Latest News Regulatory Update | 22 February 2013

Canada Implements New Labeling Update Process for Generics

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Health Canada has announced that generics companies will have soon have timely access to new safety-labeling changes made to the Product Monographs (PM) for Canadian Reference Products (CRPs), Read More...

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Latest News Regulatory Update | 22 January 2013

Brazil Updates Criteria for Drug Registration

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Brazil's national regulatory authority, Anvisa, has opened a Public Consultation on proposed revisions to the criteria for the technical requirements for quality, safety and efficacy needed to support Read More...

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Latest News | 4 December 2012

FDA Gives More Time to Generic Facilities to Register, Saying Many Have Not

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The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA), a subset of a recently Read More...

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Latest News | 22 October 2012

Court Blasts, Denies ISTA Pharmaceuticals' Challenge to ANDA Filing

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The US District Court for Washington, DC has ruled against ISTA Pharmaceuticals Inc. (PDF), which had filed suit against the US Food and Drug Administration (FDA) in a case regarding whether the Read More...

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Regulatory Update | 15 October 2012

India's CDSCO Orders Local Authorities to Adhere to Drug Regulations

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India’s Central Drugs Standard Control Organization (CDSCO) issued directions to local authorities on 12 October 2012 to comply with the requirements of the national Drugs and Cosmetics Act concerning Read More...

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Latest News | 4 October 2012

Teva Withdraws Antidepressant After Bioequivalence Concerns Validated by FDA

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The US Food and Drug Administration (FDA) has asked Israeli generic drug manufacturer Teva Pharmaceuticals to stop distribution of Budeprion XL 300, a generic version of the antidepressant Wellbutrin Read More...

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