Archives for November 2015

Edmond-Based Drug Company Responds To FDA Requests

“Qualgen’s overall goal has been, and always will be, to provide the safest, most effective sterile products to its customers,” said Shaun Riney, general manager of Qualgen. “As soon as we became aware of what the FDA was observing during its September audit, we immediately began correcting the issues.”

Happy Thanksgiving Day FromAseptic Enclosure

Dear Friends and Loyal Customers,

All of us at Aseptic Enclosure company appreciate your valued business and support throughout the year.

We are thankful and wish you a safe, happy and healthy Thanksgiving holiday!


Aseptic Enclosures awarded USP <797> and <800> Pharmacy Planning and Design agreement with Premier, Inc.

Aseptic Enclosures has been awarded a group purchasing agreement for USP <797> and <800> Pharmacy Planning and Design with Premier, Inc., a leading healthcare improvement company. Effective October 1, 2015, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier.

FDA takes action to protect consumers from potentially dangerous dietary supplements

The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.

Collegium gets tentative FDA approval for opioid painkiller

Collegium Pharmaceutical Inc said on Monday the U.S. Food and Drug Administration had tentatively approved its experimental opioid painkiller, with final approval depending on the outcome of a lawsuit filed by Purdue Pharma.

Purdue and Collegium have developed abuse-deterrent versions of the commonly prescribed and often-abused painkiller oxycontin, which contains highly addictive oxycodone.

FDA Panel Recommends Approval Of Merck Drug Sugammadex To Reverse Effect Of Muscle Relaxant

An independent panel for the U.S. Food and Drug Administration (FDA) voted unanimously for the approval of Merck & Co’s drug as safe to use to reverse the effects of muscle relaxants used during surgery.

US FDA sends letter to DNA4Life over consumer gene tests

CHICAGO (Reuters) – The U.S. Food and Drug Administration sent a letter to privately held gene testing company DNA4Life over the company’s sale of an unapproved direct-to-consumer gene test to predict drug response.

In its letter, posted on Monday, the agency said it was unable to identify any FDA clearance for the company’s test. The letter follows 23andMe’s limited relaunch last month of a series of direct-to-consumer (DTC) tests after the agency ordered the tests off the market.

DNA4Life told Reuters in an earlier interview that it did not believe it needed FDA approval to sell its test.

DNA4Life, based in Mandeville, Louisiana did not immediately respond to requests for comment.

In its letter, the FDA said the company’s test appears to meet the definition of a medical device, which requires marketing approval. The agency said the company needs to provide evidence that the device has been approved or information regarding why it believes the test does not require FDA approval.

In a statement sent to Reuters last week, FDA spokesman Eric Pahon said the FDA believes that “certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks.”

The letter comes in the wake of 23andMe’s two-year tussle with the FDA over its direct-to-consumer personal DNA testing service, which the FDA ordered off the market in 2013.

Last month, 23andMe relaunched its service with a limited number of genetic tests for carrier screening – tests that show whether an individual carries genes associated with 36 different disorders that could be passed on to a child.

23andMe still does not have FDA approval to resume the sale of tests that predict drug response.

Experts in pharmacogenetics believe those tests could be much riskier in the hands of consumers, who might use the information to make decisions about the drugs they are taking.

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FDA to hear patient complaints about commonly prescribed antibiotics

RICHMOND, Va. (WRIC) — “I am starting to lose my short-term memory, ” says Rachel Brummert.

She suffers from neurological damage and physical scars. Holding out her wrist Brummert showed 8News Investigator Kerri O’Brien, “This was a tendon rupture in my wrist.”

FDA issues guidelines for HIV drugs

The Food and Drug Administration (FDA) is looking to assert more control over HIV drug manufacturers.

Pharmaceutical companies are now facing new guidelines for developing drugs to treat Human Immunodeficiency Virus, which causes AIDS.

The FDA guidance issued Monday will provide recommendations for drug manufacturers developing HIV therapeutic biologic products and antiretroviral drugs.