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Latest News | 7 February 2013

Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Read More...


Latest News | 7 February 2013

Warning Letter Claims South Korean Device Company Failed to Implement Promised Changes

A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a Read More...


Latest News | 30 January 2013

Rare Multi-Agency Warning Letter Slams Flu Product

The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus.The letter, sent on Read More...


Latest News | 16 January 2013

Warning Letter to St. Jude Notes Quality Problems With Manufacture of ICD Leads

A warning letter sent to medical device manufacturer St. Jude Medical on 10 January 2013 by the US Food and Drug Administration (FDA) says that inspectors found numerous violations related to the Read More...


Latest News | 13 December 2012

Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility.The company, Performance Products Inc (PPI), was accused of Read More...


Latest News | 1 November 2012

Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company

A warning letter to Atrium Medical Corporation, a new Hampshire-based medical device manufacturer, claims at least four of the company's products are adulterated as a consequence of poor manufacturing Read More...


Latest News | 23 October 2012

FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc. after regulators said an inspection found deficiencies Read More...


Latest News | 18 October 2012

Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems

Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times.The report chronicles the huge Read More...


Latest News | 17 October 2012

Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority Read More...


Latest News | 16 October 2012

Crackdown on Cosmetic Marketing Claims Expands as Avon Sent Warning Letter

The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products—its fourth warning Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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