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Latest News | 21 May 2013

Regulators Reach out to Private Sector in Bid to Improve Postmarket Surveillance

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The US Food and Drug Administration (FDA) is reaching out to the private sector in a bid to help it improve the quality of the postmarketing surveillance data it receives regarding biologic drugs and Read More...


Latest News | 21 May 2013

Industry Slams Device Recall Guidance, Highlighting Perceived Flaws

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The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of Read More...


Latest News | 21 May 2013

Warning Letter to Boehringer-Ingelheim Alleges Particle Contamination, Deficient Investigations

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The US Food and Drug Administration (FDA) has released a copy of a warning letter sent last week to German pharmaceutical manufacturer Boehringer-Ingelheim, citing alleged manufacturing deficiencies Read More...


Latest News | 21 May 2013

FDA Announces Meeting Intended to Start Standardization Process for REMS

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US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a Read More...


Latest News | 21 May 2013

Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems

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Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at Read More...


Latest News | 21 May 2013

Lung Cancer Focus of Upcoming Patient-Focused Drug Development Meeting

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The US Food and Drug Administration (FDA) has announced its third meeting on patient-focused drug development, this time focusing on the views of patients with lung cancer and seeking to identify Read More...


Latest News | 21 May 2013

Industry to FDA: Give us Flexibility on Proposed Device Labeling Standards

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Earlier this year, the US Food and Drug Administration (FDA) said it wanted industry's input regarding how it could establish standardized—and mandatory—labeling for medical devices, postulating that Read More...


Latest News | 21 May 2013

Facing Major Repercussions from Bad Inspection, Impax Doubles Down on Compliance

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Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the Read More...


Latest News | 21 May 2013

Regulatory Reconnaissance (21 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Merck Insomnia Drug Suvorexant Safer at Lower Dose, FDA Staff Says (Bloomberg) (Reuters) Read More...


Latest News | 20 May 2013

Is FDA's Approach to Adaptive Clinical Trials Stunting Growth of Molecular Medicines?

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Is the right regulatory infrastructure in place in the US to accommodate a coming onslaught of pharmacogenomics data? No, it is not, and regulators need to consider a massive re-alignment of its 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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