Articles By Cyndi Root
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Weekly FDA Enforcement Report For Drugs And Biologics 6/4/14
6/9/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 4, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.
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Weekly FDA Enforcement Report For Drugs And Biologics 5/28/14
6/3/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 28, 2014. The agency publicizes recalls in its weekly report, as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily, or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.
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WuXi PharmaTech Opens New HPAPI Processing Facility In Shanghai
5/30/2014
WuXi PharmaTech announced in a press release that it has opened a new facility in Shanghai for high-potency active pharmaceutical ingredient (HPAPI) processing. WuXi’s subsidiary, Syn-The-All Pharmaceutical Co. is now processing small molecules at kilogram scale for clinical-trial supply.
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FDA To Work With Pan American Partners To Regulate Drugs
5/30/2014
Representatives from the Food and Drug Administration recently attended a steering committee meeting of the Pan American Network for Drug Regulatory Harmonization (PANDRH). PANDRH is a continental forum that seeks to harmonize drug regulation in Pan America, including North America, Central America, South America, the Caribbean, and the sub-regions. The organization has recently announced its commitment to improving its effectiveness in response to globalization.
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FDA Announces Final Guidance On Expedited Drug Review
5/30/2014
The Food and Drug Administration (FDA) has released final guidance on its expedited drug review programs. The guidance covers the four programs that the FDA developed and implemented to review drugs more quickly.
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Bayer Markets Bluetooth-Enabled Injection System For Multiple Sclerosis Patients
5/28/2014
Bayer announced in a press release that it has begun marketing a new injection system in Germany for the Bluetooth-enabled administration and monitoring of Betaferon. The BETACONNECT auto-injector is for the treatment of multiple sclerosis (MS). The system uses the myBETAapp to upload data to a smartphone or computer using a Bluetooth or USB connection. Bayer collaborated with Bang & Olufsen Medicom on BETACONNECT and associated software systems.
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NIH and NIAID Find PfSEA-1 Antigen That Protects Against Malaria
5/28/2014
The National Institutes of Health (NIH) announced in a press release that it has identified an antigen that can prevent malarial infection. The substance known as PfSEA-1 was found effective in children and adults in malaria-endemic areas. If a vaccine is formulated, it would be a valuable addition to the limited treatments available for malaria. The NIH, in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID) and its grant beneficiaries, have published the results in the May 23, 2014 issue of Science.
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Merck KGaA To Construct Drug Manufacturing Facility In Italy
5/23/2014
Merck KGaA announced in a press release that it will construct a drug manufacturing facility in Bari, Italy. The company will be investing $68 million (€50 million) to build this facility in response to the rising demand for biopharmaceuticals. The fill and finish production facility in southern Italy is expected to be operational in 2017.
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Weekly FDA Enforcement Report For Drugs And Biologics 5/21/14
5/23/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 21, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.
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Masters Pharmaceutical Responds To FDA On Ohio Drug Seizures
5/23/2014
Masters Pharmaceutical issued a press release disputing the Food and Drug Administration’s (FDA) position on the raid at Master’s subsidiary RXTPL. The FDA and U.S. Marshalls went to RXTPL’s logistics facility in Fairfield, Ohio on Thursday, May 15, 2014. The government had a search warrant based on a November 2013 inspection at Ascend Laboratories, which showed the use of unapproved drugs. Masters says that RXTPL cooperated with the government in quarantining the drugs at the facility. However, Masters takes issue with the FDA press release that states that Masters was the “distributor” of the drugs because it suggests that Masters is the owner of the drugs.