WILLIAMSBURG, Va., Feb. 23, 2009–Two new FDA quality systems compliance resources – Bulletproof Yourself against FDA Enforcement and FDA Quality Systems Records Requirements for GLPs, GCPs, GMPs – have been published by the SmarterCompliance™ newsletter and Cerulean Associates LLC.
Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters, and other reference Read the rest of this entry »

TAMPA, Fla. — Of all the fans cheering for the
fans at Raymond James Stadium by probably 2 to 1 — one small voice was particularly notable.
Shane Smith, a second grader from Paris, Pa., was at his first Steelers game, on his eighth birthday, no less. His father, Chad, sat next to him. And Chad’s former kidney was working quite nicely inside Shane’s body, courtesy of a transplant last June.
“This is unbelievable!” Read the rest of this entry »

Kolkata, Sept 14: Veteran Marxist leader Jyoti Basu, being treated at a private hospital for head injuries, Sunday underwent a CT scan as doctors said that his medical parameters were normal.
“A repeat CT scan was done (on Basu) today. The report
of the scan will be placed before the medical board on Monday
to decide the further course of action,” a bulletin issued by
the AMRI hospital said today.
It said that the team of doctors who were monitoring Read the rest of this entry »

– After first saying that they could not determine a threshold for the safe amount of certain toxic chemicals in infant formula, Food and Drug Administration officials said Friday that trace amounts are safe.
“Amounts of the industrial chemical melamine or the melamine-like compound called cyanuric acid that are below 1.0 ppm [1,000 parts per billion] do not raise public health concerns,” said Stephen Sundlof, the FDA’s director of the Center Read the rest of this entry »

Officials, groups call for significant support for FDA
President-elect Barack Obama needs to ensure strong leadership at the FDA as well as boost its financial, technological and human resources, said former agency officials, watchdog organizations and other groups. Former FDA Commissioner David Kessler said, “There’s a general perception the agency is suffering mightily.”
Thursday, November 20, 2008
Thursday, August 2, 2007
Monday, November Read the rest of this entry »

Palo Alto’s Ellin Klor would have a hard time intimidating anyone.
The 58-year-old children’s librarian is of medium height, with a physique that is more couch potato than gym rat — and a demeanor more friendly than frightening. In her free time, she knits.
But three times in the past 15 years, she’s stared down death.
Twice she battled breast cancer and won. Right before her second bout with cancer, she got stabbed in the heart by a knitting Read the rest of this entry »

) includes an updated FDA calendar of 68 expected decision dates included in the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index.
, the following FDA action has occurred:
1.) BioDelivery Sciences (
) re-submitted its Risk Evaluation and Mitigation Strategy (REMS) for pain drug candidate Onsolis (BEMA fentanyl) based on the feedback it received from the FDA’s complete response ruling on the NDA in August. Since the FDA has informed BDSI Read the rest of this entry »

(WYE) and a plaintiff over arguments about whether Food and Drug
Administration regulation of drug labeling prevents consumers from suing, in a
case that could go either way.
During oral arguments in a high-stakes pharmaceutical industry case, the
justices probed both sides for the appropriate point at which Food and Drug
Administration-approved labeling shields drug companies from lawsuits over their
products.
In this case,
lost an arm to gangrene Read the rest of this entry »

(Adds more information on drug stents in 13th paragraph, defibrillator
forecasts starting in 14th paragraph; updates share price in third paragraph.)
-(Dow Jones)- The U.S. Food and Drug Administration has informed
Boston
Scientific Corp.
(BSX) that it is removing restrictions that have blocked
approval for certain kinds of medical devices, the company’s chief executive
said Wednesday.
He also reiterated that stock selling by the company’s Read the rest of this entry »

SAO PAULO, Brazil (AP) — Doctors say Brazilian Vice President Jose Alencar is in stable condition after undergoing a 17-hour surgery to remove abdominal tumors.
The press office of the Hospital Sirio-Libanes says Alencar is recovering at the facility’s intensive care unit.
Alencar’s doctors told local media on Monday that the surgery went “very well,” but it was not clear yet when he will be able to leave the hospital.
The vice president Read the rest of this entry »