News

Latest News | 15 May 2013

FDA Finalizes Changes to Sleep Drug Labeling to Alleviate Risks of Impaired Driving

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The US Food and Drug Administration (FDA) has finalized labeling changes for zolpidem-containing products, the main ingredient in the sleep-aid drugs Ambien CR and Edluar, after issuing a warning Read More...

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Latest News | 11 April 2013

Distributor's Systemic Labeling Issues Prompt Regulators to Issue Alert

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The US Food and Drug Administration (FDA) issued a new warning on Thursday warning consumers that an inspection of a pharmaceutical distributor had unveiled troubling deficiencies, most notably that a Read More...

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Latest News | 8 April 2013

New Guidance on Molecular Diagnostics Calls for MDR Reporting for Some Unapproved Devices

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A new draft guidance issued by the US Food and Drug Administration (FDA), Molecular Diagnostic Instruments with Combined Functions, aims to clarify the standards by which federal regulators will Read More...

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Latest News | 1 April 2013

Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

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The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that Read More...

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Latest News | 22 March 2013

EU Marketing Authorization Holders Have 40 Days to Make Labeling Changes

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The European Medicines Agency (EMA) is once again warning applicants and holders of marketing authorizations to be mindful of the pending addition of Croatia to the EU, which has a number of Read More...

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Latest News | 13 March 2013

FDA Guidance Provides Framework for Testing and Labeling Scored Drug Tablets

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The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet Read More...

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Latest News | 8 March 2013

FDA Calls for Changes to Latex Labeling Statement to Reduce Confusion

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The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the labeling of medical products not made with natural rubber latex (NRL).NRL is found in numerous 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 | 14 February 2013

FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD

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The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff Read More...

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Latest News | 4 January 2013

FDA Looks to Establish Standardized, Mandatory Labeling Format for Medical Devices

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The US Food and Drug Administration (FDA) is preparing to hold a public meeting during—and before—which it plans to solicit comments on how to standardize the labeling found on medical device products Read More...

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