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  • 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...
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    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
  • 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...
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    FDA Bans Imports From Major Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US. Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market , including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and over...
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    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
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    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
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    Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Japanese Regulators Receive Orphan Drug Training from EMA Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP). Mariz has worked on the committee since ...
  • 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...
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    Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

    An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports. Background Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent. The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available a...
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    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 ...
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    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 ...
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    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...