Month: 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.” According to Riney, the fact that Qualgen …

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Aseptic Enclosures awarded USP and 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. Aseptic Enclosures USP <797> and …

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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 …

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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. Purdue Pharma …

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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. The drug sugammadex, manufactured as BRIDION by Merck, has been previously rejected several times by the FDA despite being approved …

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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 …

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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.” Thursday, Bummert will get to tell the FDA, in a rare hearing, that she …

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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. The HIV guidelines will …

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