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Advisories

U.S. Needs To Expand Monitoring After Drug Approval

May 2 | News

Drugs approved by the FDA but later re-called, such as Avandia and Vioxx, were the impetus for an Institute of Medicine committee report recommending proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market.

FDA Issues Warning Regarding Another Fake Counterfeit Cancer Medicine

FDA Issues Warning Regarding Another Fake Counterfeit Cancer Medicine

Apr 4 | News

The FDA is alerting healthcare professionals that another cancer drug, originating from a foreign source and purchased by U.S. medical practices, has been determined to be counterfeit. 

Forest, Almirall’s Aclidinium Recommended by FDA Panel

Feb 24 | News

An FDA panel on Thursday voted 12-2 that there is "substantial evidence to support approval of" Forest Laboratories and Almirall’s aclidinium to reduce complications stemming from chronic obstructive pulmonary disease (COPD).  

FDA Panel Recommends Chelsea Therapeutics' Northera

Feb 24 | News

An FDA panel on Thursday voted 7-4 to recommend approval of Chelsea Therapeutics’ Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency or non-diabetic autonomic neuropathy.

Hepatitis C Deaths Up, Baby Boomers Most at Risk

Feb 20 | News

Deaths from liver-destroying hepatitis C are on the rise, and new data shows baby boomers especially should take heed — they are most at risk.

Company Fights Move to Ban Painkiller

Nov 17 2011 | News

A South African pharmaceutical manufacturer is fighting moves toward banning a painkiller that has been removed from the shelves in the U.S. and Europe because of fears it could harm the heart.

Antibiotic Use Tied to Crohn's, Ulcerative Colitis

Sep 27 2011 | News

Study results published in the American Journal of Gastroenterology suggest that people who are prescribed a large number of antibiotics tend to have a higher risk of inflammatory bowel disease (IBD), Yahoo!Health reported. 

FDA Says Some Oral Contraceptives May Increase VTE Risk

Sep 27 2011 | News

The FDA said Monday that it "remains concerned" that drospirenone-containing oral contraceptives could raise the risk of venous thromboembolism (VTE) beyond that of other oral contraceptives following a preliminary review of several studies.  

FDA Advisers Recommend Approving Anticlotting Drug

Sep 9 2011 | News

TRENTON, N.J. (AP) — Outside advisers to the Food and Drug Administration voted Thursday to recommend that the agency approve a new anticlotting drug for use in millions more patients.

FDA Warns of Heart Risks with High Doses of Celexa

Aug 25 2011 | News

WASHINGTON (AP) — Federal health regulators are warning doctors not to prescribe high doses of the antidepressant Celexa, because of the risk of fatal heart complications.

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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