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FDA Drug Safety Podcast for Healthcare Professionals: Severe liver injury associated with the use of dronedarone (marketed as Multaq)

Jan 20 2011

On January 14, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart...

FDA Drug Safety Podcast for Healthcare Professionals: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for S...

Jan 20 2011

On January 13, 2011, the Food and Drug Administration issued a Drug Safety Communication asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of...

FDA Drug Safety Podcast for Healthcare Professionals: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

Jan 20 2011

On January 12, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer.

FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)

Jan 18 2011

On December 17, 2010, the Food and Drug Administration issued a Drug Safety Communication informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in...

FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

Jan 18 2011

On December 22, 2010, the Food and Drug Administration issued a Drug Safety Communication informing the public about results from a study conducted in France—the Santé Adulte GH Enfant, or SAGhE, study.

FDA Drug Safety Podcast: FDA reduces dose of acetaminophen in combination prescription products

Jan 18 2011

On January 13, 2011, the Food and Drug Administration issued a drug safety communication announcing that all prescription combinations of opioids and acetaminophen can no longer contain more than 325mg of acetaminophen per tablet.

FDA Drug Safety Podcast: Withdrawal of Products that Contain Propoxyphene

Dec 18 2010

On November 19, 2010 the Food and Drug Administration issued a drug safety communication about the withdrawal of products that contain propoxyphene.

FDA Drug Safety Podcast for Healthcare Professionals: FDA recommends against the continued use of propoxyphene

Dec 18 2010

On November 19, 2010, the Food and Drug Administration issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses.

FDA Drug Safety Podcast for Healthcare Professionals: Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Sy...

Dec 18 2010

On November 17, 2010 FDA issued a Stakeholder Advisory notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous, or...

FDA Drug Safety Podcast for Healthcare Professionals: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms

Oct 25 2010

On October 21, 2010, the Food and Drug Administration issued a Drug Safety Communication notifying the public that new risk information has been added to the label of the antiviral drug Invirase, or saquinavir, describing a potential change in the electrical activity of the heart when...

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Blogs

The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

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