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Regulations

New Rules for Sunscreen Manufacturers

New Rules for Sunscreen Manufacturers

May 11 | Video

New FDA regulations crack down on what sunscreen manufacturers can claim about their products.

New Year - New Recall

New Year - New Recall

Jan 11 | Blogs

It’s only a few weeks in to the New Year and it’s sad to say that 2012 is already shaping up to be as bad as 2011 was in regards to pharmaceutical product recalls.

Obama: Morning-After Pill Call Was 'Common Sense'

Dec 9 2011 | News

President Barack Obama said Thursday it was just common sense to keep girls under the age of 17 from being able to buy a morning-after contraceptive pill off a drugstore shelf.

ADT Not Linked to Increased Cardiovascular Risk

Dec 7 2011 | News

An analysis published Tuesday in JAMA finds that androgen deprivation therapy (ADT) does not appear to raise the risk of death from cardiovascular causes.

Report: Foster Kids Get High Rate of Psych Meds

Dec 2 2011 | News

Federal health officials are failing to monitor how state agencies are doling out powerful psychotropic drugs to foster children, according to a comprehensive investigation released Thursday showing foster kids are prescribed the drugs 2.7 to 4.5 times more than non-foster children and often at much higher doses.  

Shire Seeks U.S., EU Approval of New Facility

Nov 23 2011 | News

Irish drugmaker Shire PLC has filed an application with U.S. and European regulators to produce its Gaucher disease drug at a new manufacturing site in Massachusetts, saying the move will give it flexibility to meet global demand for treatments of rare diseases.

FDA Issues Warning Letter to Mylan over Manufacturing Violations

Nov 23 2011 | News

The FDA issued a warning letter to Mylan for "significant violations" of manufacturing rules identified during a February inspection of a manufacturing plant in Caguas, Puerto Rico.

Drug Info Fight Costs Vermont $1.8M

Nov 18 2011 | News

The state of Vermont is going to have to pay $1.8 million in legal expenses incurred by an opponent in a losing legal battle over access to information about what drugs doctors prescribe their patients.

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.

FDA: Minnesota Companies Agree to Halt Sale of Amino-Acid Products with Unapproved Claims

Sep 14 2011 | News

The U.S. FDA announced today that two Minnesota companies have agreed to halt distribution of amino-acid products marketed to treat a number of diseases, until requirements of the Federal Food, Drug, and Cosmetic Act are met.

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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