withstood pressure from the Richardson-Merrell company and refused Food and Drug Administration ( FDA ) approval to market thalidomide, saying further studies were needed.

* 1999 — Researchers at the Institute for Human Gene Therapy at the University of Pennsylvania accidentally kill Jesse Gelsinger during a clinical trial of a gene therapy technique, leading the FDA to halt further gene therapy trials at the Institute.

# concern by the FDA that digital mammography equipment demonstrate that it is at least as good as screen-film mammography at detecting breast cancers without increasing breast dose or the number of women recalled for further evaluation.

It was further supported by the National Academy of Sciences ( NAS ) that governmental inspections by the FDA go from reviewing plant records to compliance with its HACCP system.

A study in 1994 of radiation induced skin injuries has been performed by the Food and Drug Administration ( FDA ) followed by an advisory to minimize further fluoroscopy-induced injuries.

The agency's letter further warned that XANGO Juice had not been properly tested for safety and efficacy, and as a proposed new drug it could not be legally sold in the U. S. without prior approval of the FDA, and that the company could face enforcement action including seizure and / or injunction of products or suspension of business.

The FDA further stated in 2003 that "... A reduction in awareness provides a public health benefit, in that BIS technology can now provide anesthesiologists with a way to reduce this often debilitating, yet preventable medical error ".

The FDA has reviewed a product's GRAS claim and responded with " no comment "; i. e., no further challenges on the product's GRAS status.

* FDA CDER Office of Generic Drugs – further U. S. information on bioequivalence testing and generic drugs

An additional 34 products were recalled by the FDA on April 22, 2009, further underscoring the risks associated with unregulated " herbal supplements " to unsuspecting persons.

In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies.

A follow on Phase III study COG-ANBL0931 opened Jan 2010 to accrue 105 patients to gather further safety and efficacy data for FDA approval.

In September 2010, the FDA reversed its decision to remove Midodrine from the market and has allowed it to remain available to patients while Shire plc collects further data regarding the efficacy and safety of the drug.

The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013.

The legal status of drug formulations originally sold between 1938 and 1962 — before FDA approval was required — was ambiguous.

When the FDA failed to respond to these two petitions as required by law, Public Citizen, in January 2008, filed suit to compel the FDA to respond to their 2006 petition.

The FDA encourages manufacturers to remove 1, 4-dioxane, though it is not required by federal law.

Given its " grandfathered " status, opium tincture has never been required to undergo the strict FDA drug review and approval process.

Bottles of opium tincture are required by the FDA to bear a bright red " POISON " label given the potency of the drug and the potential for overdose ( see discussion about confusion with Paregoric below ).

The FDA required that Celgene Corporation, which planned to market thalidomide under the brand name Thalomid, establish a system for thalidomide education and prescribing safety ( STEPS ) oversight program.

Biotechnology labeling is not required by the Food and Drug Administration ( FDA ), but it has been adopted by over 40 countries.

While pharmaceutical companies are required to obtain FDA approval, which involves assessing the risks and benefits prior to their entry into the market, dietary supplements do not need to be pre-approved by FDA before they can enter the market.

Natural colors are not required to be certified by a number of regulatory bodies throughout the world, including the United States FDA.

A sustained-release form of growth hormone, Nutropin Depot ( Genentech and Alkermes ) was approved by the FDA in 1999, allowing for fewer injections ( every 2 or 4 weeks instead of daily ); however, the product was discontinued by Genentech / Alkermes in 2004 for financial reasons ( Nutropin Depot required significantly more resources to produce than the rest of the Nutropin line ).

In 2003, the Food and Drug Administration ( FDA ) required all manufacturers of atypical antipsychotics to change their labeling to include a warning about the risks of hyperglycemia and diabetes with atypical antipsychotics.

The settlement required GSK to post a registry which would include much more information about pretrial and clinical drug study results than what the U. S. Food and Drug Administration ( FDA ) and other pharmaceutical companies had thus far been willing to make public.

The FDA required in 1973 that cancer-causing compounds must not be present in meat at concentrations that would cause a cancer risk greater than 1 in a million lifetimes.

However, new FDA rules required that by June 2010 all production of dietary supplements must comply with " current good manufacturing practices " ( cGMP ), and be manufactured with " controls that result in a consistent product free of contamination, with accurate labeling.

" In addition, the industry has been required to report to the FDA " all serious dietary supplement related adverse events " and the FDA has, within the cGMP guidelines, begun enforcement of that requirement.

Caffeine dosage is not required to be on the product label for food in the United States, unlike drugs, but some advocates are urging the FDA to change this practice.

Just weeks before the Super Bowl, the FDA required more possible side effects to be listed in the advertisement, including priapism.

In 1971, P & G met with the Food and Drug Administration ( FDA ) to examine what sort of testing would be required to introduce olestra as a food additive.

However, the lengthy series of studies that followed failed to demonstrate the 15 % reduction required by the FDA to be approved as a treatment.

Manufacturers of products falling into this category are not required to prove the safety or efficacy of their product, though the FDA may withdraw a product from sale should it prove harmful.

Consequently, drugs were then required to have Food and Drug Administration ( FDA ) approval before being marketed to consumers.

His letter was spurred by statements earlier in 2008 by Dr. Andrew Mosholder, an FDA official, who had told senators at a 2 February 2004 hearing that " GlaxoSmithKline, in his opinion, was attempting to ' sugar-coat ' the adverse effects of Paxil on children by ' miscoding ' suicidal ideations and / or suicidal behaviour.

In December 2008, StemCells Inc., a biotech company in Palo Alto, received clearance from the U. S. Food and Drug Administration ( FDA ) to conduct Phase I clinical trials in PMD to assess the safety of transplanting human neural stem cells as a potential treatment for PMD.

The United States Food and Drug Administration ( FDA ) asked Pillsbury to organize and conduct a training program on the inspection of canned foods for FDA inspectors.

Regulatory agencies ( including the FDA in the U. S. and regulatory agencies in many European nations ) are authorized to conduct unannounced inspections, though some are scheduled.

Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is " sufficiently complete to permit a substantive review ".

As of 2005, the for-profit Western Institutional Review Board claimed to conduct the majority of reviews for new drug submissions to the FDA.

A Food and Drug Administration ( FDA ) investigation concluded that the scientists involved in the trial, including the co-investigator Dr. James M. Wilson ( Director of the Institute for Human Gene Therapy ), broke several rules of conduct:

Adam's mentor, Dr. Max Rudolph, takes a slight detour from his ethical conduct and gives an FDA unapproved life saving cancer treatment whose efficacy is proved in his laboratory, to Hartnell.