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Regulations

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.

Merck & Co. Receives Subpoena from U.S. Regulators

Aug 9 2011 | News

Merck & Co. disclosed Monday in an SEC filing that it received a subpoena from the U.S. Department of Justice as part of a "federal health care investigation under criminal statutes" into the company’s marketing of three drugs acquired in its merger with Schering-Plough.

Blogs

When Is Software The Answer To Regulatory Concerns About Your Investigations?

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Jan 30 | John Ager, Technical Consultant, Life Science, Kepner-Tregoe, Inc

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.

The Benefits of Professional Project Management

The Benefits of Professional Project Management

Jan 13 | Thorsten Vammen, Director at GEA Liquid Processing in Skanderborg, Denmark

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.

Multimedia

Battle over Birth Control

Battle over Birth Control

Feb 9 | Video

CNN’s The Situation Room discusses the current dispute over health care coverage for contraception. Will there be a contraception compromise?

Government Seeking $1T Campaign Against Alzheimer's

Government Seeking $1T Campaign Against Alzheimer's

Jan 18 | Video

Government advisors tried to set priorities for a national campaign to treat and manage Alzheimer's disease, which is projected to cost more than a trillion dollars in care by 2050. But as Dr. Jon LaPook reports, the plan does not include any funding.

ADHD Drugs in Short Supply

ADHD Drugs in Short Supply

Jan 11 | Video

Parents of children with attention deficit disorders are forced to travel from pharmacy to pharmacy in search of prescription medicines with no guarantees they will be available.

Study: Link Between Statins And Diabetes

Study: Link Between Statins And Diabetes

Jan 10 | Video

A recent study reveals that women who take statins may have a greate chance of developing diabetes.

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