Regulatory Affairs Syndicator

“In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk.”

A loss of scientific expertise at the Food and Drug Administration is threatening American lives, advisers to the embattled consumer protection agency conclude in a report released Friday.

Food safety in particular is in crisis, concludes the nearly yearlong review by scientists from leading universities and industries the FDA regulates.

Scary headlines from recent years _ heart-damaging drug side effects, deadly E. coli in spinach, pets dead from chemically spiked food, toxic toothpaste _ have triggered growing questions about FDA’s ability to safeguard the public. Indeed, the new report is the latest in a list of outside reviews to conclude the cash-strapped FDA has trouble keeping pace with the $1 trillion worth of consumer goods it regulates. Read more

“This approval from the FDA is important because data from our Cymbalta clinical trial demonstrate that continuing to treat the patient delays the time to possible relapse”

Federal regulators have approved Eli Lilly and Co.’s antidepressant medication Cymbalta for long-term use to help patients avoid a relapse into depression, the company said Friday. via WHAS-TV Louisville

FDA Panel Backs Heart-Pump DeviceWall Street Journal - 7 hours agoBy JENNIFER CORBETT DOOREN WASHINGTON — A Food and Drug Administration panel Friday backed a heart-pumping device from Thoratec Corp. …Panel urges FDA to back new Thoratec heart …

American ChronicleHealth and Wellness Product Information is Everywhere!American Chronicle, CA - 12 hours agoIn fact most do not even qualify to be evaluated by the Food and Drug Administration. Dietary supplements do not need approval from …

China pledges safe food, toy exports ahead of holiday seasonXinhua, China - 9 hours agoShao Mingli, head of the State Food and Drug Administration (SFDA), said the administration has taken back 157 Good Manufacturing Practice (GMP) …

China pledges safe food, toy exports ahead of holiday seasonXinhua, China - 1 hour agoShao Mingli, head of the State Food and Drug Administration (SFDA), said the administration has taken back 157 Good Manufacturing Practice (GMP) …

Inside INdiana Business (press release)FDA Approves Cymbalta(R) for Maintenance Treatment of Major …Reuters - 2 hours ago(NYSE: LLY) announced today that the US Food and Drug Administration (FDA)has approved Cymbalta(R) (duloxetine hcl) for the…

Avastin panel tops make-or-break period for RocheReuters - 50 minutes agoThe US Food and Drug Administration has delayed approval of Avastin as a first-line treatment for metastatic breast cancer but its advisory panel will …Roche May Take Chol…

Penalty guidelines set for fake drugsChina Daily, China - 3 hours ago… to be subject to such penalties, according to a draft rule made public by the State Food and Drug Administration (SFDA) on Wednesday for public comment. …China plans t…

Javno.hrCORRECTION: Tainted pet food killed 200 dogs and cats: studyReuters - 4 hours agoThe US Food and Drug Administration said it received 17000 complaints of related pet deaths, although it had confirmed just 16. …MSU survey determines that …

Trinity Biotech Announces FDA Clearance of tristat(TM) Point-of …Reuters - 16 hours ago… today announced that the US Food and Drug Administration has given clearance to market the rapid, point-of-care tristat(TM) hba1c system. …Trinity Biote…

Food and Drug Administration grants six-month extension to …CNNMoney.com - 33 minutes ago29, 2007 (Thomson Financial delivered by Newstex) — astrazeneca (NYSE:AZN) Thursday said the Food and Drug Administration had granted a six-month extensio…

Genedata Provides Expressionist Platform to US Food and Drug …GenomicsProteomics.com (press release), UK - 10 hours agoWeida Tong, Director of the Center for Toxicoinformatics at the US Food and Drug Administration (FDA), said, “Given the…

‘Stop smoking’ drug: It makes you feel suicidalWhat Doctors Don’t Tell You, UK - Nov 29, 2007In the US, its drug regulator, the Food and Drug Administration (FDA), has already expressed concerns about the drug, which is manufactured by Pf…

Dog Flu Diet and DiseasesNovartis Drug Carries Pregnancy RisksMotley Fool - 3 hours agoThe Food and Drug Administration alerted physicians and patients to the risks late Tuesday and said women who are planning a pregnancy should only use …Novart…