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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Akzo Nobel Chemicals, Beckman Coulter, Coco Kefir, DreamLife, GD Designs, H&A Mu...

Akzo Nobel Chemicals Has CGMP Problems

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FDA warns Akzo Nobel Chemicals about CGMP violations in its Mexican API manufacturing facility.

FDA, FTC Move Against Homeopathic Diet Drugs

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FDA and the Federal Trade Commission issue seven Warning Letters to companies marketing OTC homeopathic human chorionic gonadotrop...

Senator Brown Introduces Streamlined De Novo Device Bill

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Sen. Scott Brown (R-MA) introduces a bill to streamline CDRH's de novo classification process for medical devices.

Enforcement Speed is a Top Priority, ORA Chief Says

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FDA ORA chief Howard Sklamberg tells an FDLI conference that the agency's enforcement speed is a top priority for 2012.

Comments Extended on Tobacco Sales

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Federal Register Advance notice of proposed rulemaking: FDA extends the comment period on non-face-to-face sale and distribution o...

CBER Seeks Site Visit Training Participants

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Federal Register Notice: CBER seeks participants in its Regulatory Site Visit Training Program.

Will FDA Allow Plan B on Store Shelves?

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FDA is expected to rule this week on whether Tevas Plan B emergency contraceptive can be sold openly on store shelves.

How Well is FDA Protecting the Population?

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Consulting editor John Scharmann considers the regulatory issues presented by increasing imports of drugs and drug components in a...

Spectrum Files IND for Hyperphosphatemia Therapy

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Spectrum Pharmaceuticals submits an IND application for SPI-014, a second-generation lanthanum-based nanoparticle phosphate bindin...