Posts Tagged ‘FDA’« Older Entries
Complimentary presentation from ACI’s 23rd FDA Boot camp.
Highlights from this presentation:
- FDA’s GMP philosophy
- Substantive drug areas
- Sources of GMPs
- FDA Inspection triggers
- Typical investigation activities and much more…
May 15th, 2014
in Pharmaceuticals / Biotech / Life Sciences |
When: Wednesday, June 04 to Friday, June 06, 2014
Where: InterContinental New York Barclay, New York, NY
To learn more, visit: AmericanConference.com/biosimilars
by Jordan Grotzinger, Originally Published on consumerproductscounselor.com
California isn’t exactly known as a business-friendly state. In some ways, the governor has tried to change that. He’ll have an interesting choice to make if a recently-passed senate bill reaches his desk.
Pharma & Healthcare – the latest on FDA’s proposed generic drug labeling rule, FDA bans imports from India’s Sun Pharma and more.
Pharma & Healthcare – the latest on Pfizer Inc v. Teva Pharmaceuticals, the USFDA imposes penalties on Indian pharma cos’ and more.
FDA panel could give Bayer painkiller an edge over rivals from Pfizer, J&J by Tracy Staton Published on FiercePharma.com
What if every drug in a class posed a risk to the heart–all except one? That’s the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world… [ Read More ]
‘USFDA has imposed disproportionate penalties on Indian pharma cos’ by Amiti Sen Published on The Hindu Business Line
Reacting strongly to the recent string of actions against Indian pharmaceutical companies by the US Food & Drug Administration (FDA), India has said that in some cases the authority has imposed disproportionately strong penalties…[ Read More ]
Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014) by Andrew Williams Published on jdsupra.com
The standard of review at the Federal Circuit is important. Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court’s factual determinations…[ Read More ]
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From our good friends at the FDA:
Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC),” said Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Fabricant. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
On October 22, 2013, the FDA reported that Reser’s Fine Foods of Beaverton, OR was recalling approximately 109,000 cases of refrigerated ready-to-eat products because it may be contaminated withListeria monocytogenes. The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.
It reported: NO illnesses have been reported to date.
On October 24, 2013, the FDA reported that Boston Salads and Prepared Foods of Boston, MA was voluntarily recalling prepared salads, because they have the potential to be contaminated with Listeria monocytogenes. Product was distributed throughout the MA, CT, RI, VT, and ME states to wholesale and food service distributors, and retail stores.
It reported: There has been no illness or complaints related to this recall.
On October 25, 2013, the FISS reported that Garden Fresh Foods of Milwaukee, WI was recalling approximately 103,080 additional pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes. The company was recalling these products in addition to the 25,748 pounds of similar products that were recalled on Sept. 25 and Oct. 17, 2013.
It reported: FSIS and the company have not received reports of illnesses due to consumption of these products.
On October 25, 2013, the FSIS reported that Taylor Farms of Jessup, MD was recalling approximately 5,084 pounds of broccoli salad kit products. The kits contain salad dressing in packets that were the subject of a Food and Drug Administration (FDA) recalldue to concerns about possible Listeria monocytogenes contamination. The salad kits were shipped to distributors and retail locations (delis) for consumer purchase in Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York and Vermont.
It reported: FSIS, FDA and the company have received no reports of illnessesassociated with consumption of these products.
On October 26, 2013, the FSIS reported that Reser’s Fine Foods of Topeka, KS was expanding its recall of chicken, ham and beef products to include all products produced between Sept. 5 and Oct. 9, 2013. This was in addition to the 22,800 pounds of product recalled on Oct. 22, 2013. The products are being recalled due to possible contamination with Listeria monocytogenes.
It reported: FSIS and the company have not received reports of illnesses due to consumption of these products.
Then on October 26, 2013 the FDA reported that Reser’s Fine Foods of Beaverton, OR was voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.
Then it changed the wording regarding illnesses to: There are no confirmed illnessesassociated with these products.
Illnesses linked to the above recalls or not?
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Pharma & Healthcare – The latest on Sun Pharma shares, Valeant Settlement, and more.
Shares of Sun Pharmaceutical Industries Ltd(SUN.NS) fell as much as 2.1 percent after Bloomberg News reported the drug maker had received queries from the U.S. Food and Drug Administration over quality control at a U.S. subsidiary.
Sun received two so-called Form 483s, issued when the U.S. regulator has queries, for its Detroit-based Caraco Pharmaceutical Laboratories Ltd following inspections in January and May this year, Bloomberg reported on Monday, citing a Freedom of Information Act request… [ Read More ]
Valeant Pharma to pay Anacor $142.5M in settlement by Bloomberg Business Week on Bloomberg Business Week
NEW YORK (AP) — Valeant Pharmaceuticals will pay Anacor Pharmaceuticals $142.5 million in a settlement, the companies said Monday.
The payment will be made by Nov. 8, and it will resolve all disputes between Anacor and Valeant. That includes legal proceedings involving Medicis Pharma, which Valeant acquired in December.
Anacor says that Dow Pharmaceutical Services, which is now part of Valeant, breached a contract related to Anacor’s work on Jublia. The drug is a treatment for onychomycosis, a fungal infection of the nail and nail bed. On Oct. 18 an arbitrator awarded Anacor $100 million in damages and ordered Valeant to pay costs and attorney’s fees as well. Anacor, of Palo Alto, Calif., said it believed it had other claims against Valeant as well… [ Read More ]
Is It Pharma’s Fault That We Don’t Have Better Drugs For Malaria, TB And Tropical Diseases? by John LaMattina on Forbes
“Despite some high-profile commitments from some of the industry’s largest innovators, R&D for some of the world’s most deadly neglected diseases remains underfunded and unimpressive, according to a study, a state of affairs that has barely improved over the last three decades.”
So starts an article by Damian Garde of FierceBiotech. Garde is referring to a recent paper in “The Lancet” entitled: “The drug and vaccine landscape for neglected diseases (2000 -11): a systematic assessment.” Neglected diseases are defined as diseases that affect people in low-income countries and are the leading cause of mortality, chronic disability and poverty. They include malaria, tuberculosis, diarrheal diseases, and tropical diseases. The Lancet paper made the following points… [ Read More ]
Sun Pharma says issues with USFDA at Caraco facility addressed by The Economic Times
NEW DELHI: Drug maker Sun Pharmaceutical today said it has addressed the US health regulator’s concerns about manufacturing lapses at its US-based Caraco Pharmaceutical Laboratories. United States Food and Drug Administration had conducted inspections in January and May this year and had noticed the lapses.
When asked about the nature of lapses and the corrective measures the company has taken a Sun Pharmaceutical spokesperson said they were “minor observations”.
“The company has responded to these a long time back,” the spokesperson said without elaborating. Earlier in the August 2012, Sun Pharmaceutical Industries had said American health regulator had approved resumption of manufacturing operations at Caraco for two drugs after inspections of facilities… [ Read More ]
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Press Release from FDA, Released on 09/20/2013
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label…. [ Read More ]
When: Tuesday, November 05 to Wednesday, November 06, 2013
Where: Millennium Knickerbocker Hotel, Chicago, IL
To Learn More, Visit: www.americanconference.com/fdabootcamp-devices
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Pharma & Healthcare – the latest on DEA probe, False Claims Act, Pfizer and more.
Costco says cooperating with DEA probe on controlled substances by Jessica Wohl Editing by Leslie Adler and Bob Burgdorfer Posted on Reuters
Costco Wholesale Corp (COST.O) said on Wednesday that it will cooperate with the U.S. Drug Enforcement Administration in its ongoing investigation of prescriptions for controlled substances, after receiving subpoenas and warrants from the DEA. The DEA has targeted large pharmacy chains and distributors to stem the flow of prescription drugs where abuse is suspected… [ Read More ]
Supreme Court Considering False Claims Act Appeal by Brian Mahany Posted on jdsupra.com
The Supreme Court is considering an appeal from the 4th Circuit regarding the specificity necessary when pleading false claims act cases. The issue has serious implications for whistleblowers who can only document indirect frauds against government programs… [ Read More ]
Early Promise in Drug Trial for Fighting Cholesterol by Andrew Pollack Posted on the NYTimes.com
A new type of lipid-lowering drug being developed by Sanofi and Regeneron Pharmaceuticals cut cholesterol levels by about half in its first late-stage clinical trial, the companies will announce on Wednesday. The drug, called alirocumab, is one of a new class of potentially powerful cholesterol fighters that have excited doctors and investors alike, spurring a heated race to market among Sanofi, Amgen, Pfizer and other companies… [ Read More ]
Pfizer gets European approval for label update of pneumococcal conjugate vaccine Prevenar 13 by pharmaceutical-technology Posted on pharmaceutical-technology
Pfizer has received European Commission approval for updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain high-risk populations. The updated label now contains information about the use of Prevenar 13 in preterm infants, children and adolescents with sickle cell disease who were earlier treated with the 23-valent pneumococcal polysaccharide vaccine…[ Read More]
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