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Last updated on April 18, 2014 at 21:21 EDT

Latest Medicines and Healthcare products Regulatory Agency Stories

2014-02-27 23:00:31

Agaram Technologies is delighted to announce that it has won a prestigious contract with National Institute of Biological Standards and Control (NIBSC), UK, for supply, implementation and support of our QuaLIS LIMS with LogiLab ELN and SDMS suite of products. Chennai (PRWEB) February 28, 2014 Agaram Technologies has been awarded a contract by National Institute of Biological Standards and Control (NIBSC), UK, for supply, implementation and support of its QuaLIS LIMS range of products....

2014-01-08 04:21:09

MANCHESTER, N.H., Jan. 8, 2014 /PRNewswire/ -- Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that the Food and Drug Administration (FDA) recently completed an inspection of their Manchester manufacturing facility. This is the sixth successful inspection of the site, which is currently functioning as a multiproduct medical device manufacturing facility. The November 2013 inspection was a combination FDA...

2013-12-16 16:25:28

EAST RUTHERFORD, N.J., Dec. 16, 2013 /PRNewswire/ -- Cambrex Corporation (NYSE: CBM, "Cambrex") announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex's active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no Form 483 observations were issued. The US FDA authorities inspected the facility from...

2013-08-20 08:28:55

-MHRA inspection confirms Nelson Laboratories compliance with European standards- SALT LAKE CITY, Aug. 20, 2013 /PRNewswire/ -- Nelson Laboratories today announced the successful receipt of the European Union's Good Manufacturing Practice (GMP) Compliance Certificate after the Medicines and Healthcare products Regulatory Agency (MHRA) inspection of the laboratory's facilities and processes. (Logo: http://photos.prnewswire.com/prnh/20120727/LA47745LOGO) "Manufacturers are obligated...

2013-08-07 04:21:14

LSNE's Bedford, New Hampshire Manufacturing Facility Receives Certificate of GMP Compliance from MHRA MANCHESTER, N.H., Aug. 7, 2013 /PRNewswire/ -- Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that their 25 Commerce Drive, Bedford NH facility received a Certificate of GMP Compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products...

Britain Tightening Regulations On E-Cigarettes
2013-06-12 16:19:23

Lee Rannals for redOrbit.com — Your Universe Online Britain's medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), said this week that electronic cigarettes and similar products containing nicotine will be undergoing some stricter regulations in 2016. MHRA said that in three years e-cigarettes will require a license, treating the vapor smokes the same way as other over-the-counter medicines. The regulator said the various varieties of e-cigarettes...

2012-08-23 02:26:11

BETHESDA, Md., Aug. 23, 2012 /PRNewswire/ -- Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) announced today that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom (the U.K.'s "FDA"), for the Company's 300-patient Phase III clinical trial of DCVax(®)-L immune therapy for Glioblastoma multiforme brain cancer (GBM) to proceed in the U.K. (Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO) This Phase III...

2012-06-18 02:26:42

SEATTLE, June 18, 2012 /PRNewswire/ -- CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA inspected CMC Biologics' manufacturing and testing facilities in Bothell, WA in late March 2012 and issued the certificate...

115807489
2012-03-14 06:35:36

According to a new study published in the Lancet journal, there is unequivocal evidence of high failure rates of metal on metal hip replacements, especially in women. The data showed that on more than 400,000 hip replacements, metal on metal types needed revising more often than other types. Those found in women were especially prone to failure. The researchers say that tiny metal ions, made of cobalt and chromium, break off the implant and leach into the blood. This causes muscle, bone...

2012-03-08 08:00:00

As reported on BBC on February 28th 2012, the British Medicines and Healthcare products Regulatory Agency (MHRA) advised that patients who have undergone large head metal-on-metal hip replacements should be monitored annually for life. In July 2008 hip replacement components made by Zimmer Holdings, Inc. were recalled after it was learned that the surgical parts did not work properly, forcing many patients to undergo painful and costly additional surgeries to correct the defect. The Zimmer...