Keyword: Food and Drug Administration (FDA)

News

FDA Reform Act Signed into Law

20.07.2012 - In a major victory for the American people, President Obama recently signed into law the U.S. Food and Drug Administration's Safety and Innovation Act that will allow the U.S...

News

EU Agency Lifts Lid on Drug Data Secrets

15.07.2012 - Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl...

News

K-V Sues FDA over Makena in Fight for Survival

06.07.2012 - K-V Pharmaceutical is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the...

News

GlaxoSmithKline Settles Healthcare Fraud Case for $3 Billion

03.07.2012 - GlaxoSmithKline agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare...

News

FDA OKs First Obesity Drug in 13 years

28.06.2012 - U.S. health regulators approved the first new weight-loss drug in 13 years, allowing Arena Pharmaceuticals to bring its Belviq pill to market as public health advocates push for...

News

Shire Hit as U.S. Approves New Generic ADHD Drug

25.06.2012 - U.S. regulators have ruled against Shire in a battle over generic copies of its hyperactivity drug Adderall XR, approving a cut-price version of the medicine from Actavis, which is...

News

Survey Shows Dim Faith in Lilly, Pfizer Alzheimer's Drugs

20.06.2012 - Institutional investors doubt that treatments for Alzheimer's disease being developed by Pfizer and Eli Lilly will achieve the main goals of their ongoing late-stage trials, but...

Plant Construction & Process Technology

Vaccine Production: ‘Best-in-Class’

27.01.2012 - The production of pharmaceutical products requires strict compliance with specified ambient conditions. Since the building automation systems (BAS) must meet very special...