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Guidance on E-Submissions for Clinical Site Dataset

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Federal Register Notice: FDA releases a draft guidance, Providing Submissions in Electronic Format Summary Level Clinical Site Da...

FDA Approves sNDA for Rescula in Glaucoma

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FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula ophthalmic solution to allow its use as a first-line therapeut...

Matrixx Recalls 1 Zicam Nasal Gel Lot

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Matrixx Initiatives recalls one lot of Zicam Extreme Congestion Relief nasal gel after finding a small amount of Burkholderia cepa...

Panel to Discuss Drugs Containing Hydrocodone

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 1/24-25/13 to discuss drugs containing ...

FDA Holds Hearing on Opioid Drugs

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Federal Register Notice: FDA plans a public hearing 2/7-8 to obtain information on the use of opioid drugs in treating chronic pai...

Manufacturing vs. Compounding Line Hard to Draw, FDA Told

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FDA is told by state representatives that the defining differences between compounding and manufacturing remain the major problem ...

Supplements Recalled Due to Undeclared Ingredients

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Performance Plus Marketing recalls Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supr...

Guidance on Certification for Medical Gases

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Federal Register Notice: FDA releases a draft guidance, Certification Process for Designated Medical Gases.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Axiobionics, Basic Organics, Leisure Products, and Prime Herbs Corp.

FDA Approves Mylans Generic Qualaquin

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Mutual Pharmaceutical Co.s antimalarial Qualaquin.