Author Archives: C. Kubler

FDA ISSUES FAQ GUIDANCE FOR CGMP FOR PET DRUGS

UPDATE: FDA has posted new draft guidance – FDA Oversight of PET Drug Products, Questions and Answers.

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FDA TO OFFER WEBINAR ON CGMP FOR PET DRUGS

The Food and Drug Administration (FDA) has announced a webinar on CGMP for PET drugs.

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FDA ANNOUNCES MEETING ON GENERIC DRUG USER FEE ACT

The FDA has announced a public meeting to discuss the proposed Generic Drug User Fee Act.

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ADDITIONAL INFORMATION PROVIDED BY FDA

In response to an inquiry, the Food and Drug Administration (FDA) has answered several remaining questions.

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FDA EXTENDS FILING DEADLINE FOR PET RADIOPHARMACEUTICALS

The Food and Drug Administration (FDA) has issued an extension to the December filing deadline for Positron Emission Tomography (PET) radiopharmaceuticals.

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FDA ISSUES NEW GUIDANCE FOR PET CGMP INSPECTIONS

The Food and Drug Administration (FDA) has posted new guidance for compliance with PET CGMP inspections.

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FDA WEBINAR ON DRUG MASTER FILES

The Food and Drug Administration (FDA) will offer a webinar entitled “Introduction to the Drug Master File (DMF)”.

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FDA POSITION ON INDS FOR PET DRUGS IN CLINICAL TRIALS

Recent questions posed to the FDA regarding the requirement for INDs for PET drugs used in clinical trials has drawn a clarifying response from the FDA on its position.

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FDA ISSUES DRAFT GUIDANCE ON MEDIA FILLS OF ASEPTIC PREPARATIONS FOR PET DRUGS

The Food and Drug Administration (FDA) has issued a draft guidance entitled “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs”.

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FDA TO HOLD ANNUAL INSPECTIONS SUMMIT

The U.S. Food and Drug Administration (FDA) announced its Sixth Annual Inspections Summit to be held October 4 – 6, 2011.

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