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  • Regulatory NewsRegulatory News

    Drug Marketing on Twitter: FDA to Study Space-Limited Communications

    The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited. "The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communicati...
  • Regulatory NewsRegulatory News

    FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

    The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades. On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under developm...
  • Regulatory NewsRegulatory News

    MHRA Delays Nordic Pharma’s Attempt to Add New Indian CMO Site to Marketing Authorization

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance. An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major...
  • Regulatory NewsRegulatory News

    FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

    Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday. For the Italian site, which produces both APIs and finished drugs, FDA’s inspection from last May (warning letter was sent 24 May 2016) uncovered sterility concerns, including visible “black ...
  • Feature ArticlesFeature Articles

    What Is 'Regulatory Intelligence?'

    This article provides an overview of regulatory intelligence, including identifying sources, using tools for gathering information, and the importance of recognizing copyright restrictions . Regulatory intelligence is the regulatory information you have been asked to gather and provide regarding topics of importance to your audience. For example, you may be asked to inform your company of any medical device-related items in the Federal Register or of FDA warning or un...
  • Regulatory NewsRegulatory News

    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...
  • Regulatory NewsRegulatory News

    Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

    The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as re...
  • Regulatory NewsRegulatory News

    FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

    Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. On Wednesday, FDA added Xinxiang Pharmaceutical Co. and  Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are sub...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (22 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls for Investigation Into Sellers of $88M Worth of Improperly Refrigerated Vaccines The China Food and Drug Administration (CFDA) is pressuring local government officials to probe the sale of RMB 570 million ($88 million) worth of improperly refrigerated vaccines. Police officials think the substandard vaccine ring, which was allegedly run by a mother and daughter t...
  • Regulatory NewsRegulatory News

    MHRA Takes Action on LinkedIn Pharma Marketing

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn. MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, accor...
  • 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

    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...