Search Results for Drug Quality and Security Act

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With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance By Alexander Gaffney, RAC - Published 09 December 2014

With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Distribution, Generic drugs, Prescription drugs

Tags: DSCSA, Drug Quality and Security Act, Drug Supply Chain Security Act, Guidance, Draft Guidance, Supply Chain

FDA Guidance: Federal Efforts to Secure Supply Chain Trump State Efforts By Alexander Gaffney, RAC - Published 08 October 2014

US regulators have released more information regarding an emerging system intended to prevent counterfeit medicines from reaching US consumers.

Categories: News, US, CDER, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging

Tags: DQSA, DSCSA, Drug Quality and Security Act, Drug Supply Chain Security Act, Preemption

In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect By Alexander Gaffney, RAC - Published 04 September 2014

A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well.

Categories: News, US, CDER, Drugs, Manufacturing, Regulatory strategy

Tags: 503A 503B, Pharmaceutical Compounding, Compounding, DQSA, Drug Quality and Security Act, Difficult-to-Compound List

As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 503(b)(1), Prescription Drug, Alli, Drug Quality and Security Act, DQSA, OTC, GSK, Track and Trace, Latest News, pharmaceutical, drug

FDA Releases Trio of Compounding Guidances Just Days After DQSA Signed into Law By Alexander Gaffney, RF News Editor - Published 02 December 2013

Categories: US, FDA

Tags: Drug Quality and Security Act, DQSA, Pharmaceutical Compounding, Compounding, Legislation, Latest News, draft guidance

Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: Drug Quality and Security Act, DQSA, Pharmaceutical Compounding, Compounding, Track and Trace, Legislation, Latest News