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  • Regulatory NewsRegulatory News

    French Biotech’s Manufacturing Operations Suspended by ANSM

    France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November. ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The comp...
  • Regulatory NewsRegulatory News

    In Focus: The Top News Stories from 2015

    For RAPS’ Regulatory Focus , 2015 might simply be called: The Year of the Explainer. With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics: 9. After Three-Year Delay, FDA Finalizes Guidance Do...
  • Regulatory NewsRegulatory News

    UK Agencies Look to Overhaul Cancer Drugs Fund

    The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected. As many in the UK, like the US, are distraught over the rise of cancer drug prices, NICE and NHS are proposing to turn the CDF, beginning in April ...
  • Regulatory NewsRegulatory News

    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...
  • Feature ArticlesFeature Articles

    FDA Social Media Guidance–Lessons Learned from the Comment Period

    This article reviews and summarizes public comments on FDA's two draft social media guidance documents. In the past, traditional drug and device promotion came in the form of paper collaterals–sales aids, booth panels, slim jims* and the like. As we entered the internet age, companies found new avenues to get their product promotional messages out. Broadly defined as "social media," new forms of product communication now include interactive websites with sharing capabi...
  • Feature ArticlesFeature Articles

    Social Media: Changing the Rules for Regulatory Professionals

    This article discusses social media's role in the changing regulatory landscape and how regulatory professionals must evolve to ensure compliance with FDA requirements specific to the medical device field. As social media rapidly evolves via the internet, digital media platforms, new technologies and mobile applications enhancing the marketers' ability to create and deliver more personalized, segmented solutions to medical device users, regulatory professionals also ne...
  • Regulatory NewsRegulatory News

    The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

    It's already been a busy, busy year here at Regulatory Focus. During the first quarter alone, more than a quarter million of you have read more than half a million of our articles—a new record for Focus , and hopefully a testament to the value of the content we're producing on a daily basis. But which articles have attracted your collective attention the most? Read on to discover the top 10 articles in Focus so far this year. The Top 10 10.) FDA Launches New Drug ...
  • Regulatory NewsRegulatory News

    Free the Tweets: Group Asks FDA to Allow its Scientists to Use Social Media

    The US Food and Drug Administration currently lacks any policy permitting its employees to discuss scientific issues on social media channels like Twitter and Facebook, a new report by the scientific advocacy group Union of Concerned Scientists (UCS) has found. The findings, outlined in the report " Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies ," are meant to spur discussion about whether FDA's employees are free to speak ...
  • Regulatory NewsRegulatory News

    The Top 15 Biologics Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of biologics manufacturing facilities, indicating the most common issues faced by biologics companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014. T...
  • Regulatory NewsRegulatory News

    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
  • Regulatory NewsRegulatory News

    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • Regulatory NewsRegulatory News

    FDA Warns Company for 'Liking' Status on Facebook

    The US Food and Drug Administration (FDA) has issued a rare Warning Letter chiding a company for, among other reasons, improperly "liking" certain unapproved claims about its product on Facebook. The letter, sent to Utah-based dietary supplement manufacturer Zarbee's, is primarily focused on the company's marketing claims, which FDA says cause the company's products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under federal law, dietary supple...