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  • Feature ArticlesFeature Articles

    Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1

    • 25 April 2013
    The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to enhance patient safety by avoiding medical errors and improving communications, while reducing costs and inefficiencies in areas such as record keeping. 1 Because of this potential to improve health systems, the use of eHealth technology to aid in medical diagnosis and treatment and support pharmaceutical communication will likely become increasingly commo...
  • FDA Gets Go-Ahead for Study of DTC Advertising and Social Media

    The US Food and Drug Administration (FDA) will move forward with a survey of healthcare professionals regarding their opinions and perceptions about prescription drug promotion after receiving approval from the Office of Management and Budget (OMB), the executive branch's regulatory clearing house. Background FDA's intent to conduct the survey was first announced in January 2012, when it said in a Federal Register posting that it was soliciting comments on a propo...
  • SEC Out with New Social Media Policy, But Parallels for FDA are Few

    For the second time in as many weeks, a major regulatory agency has announced the release of a new social media policy governing interactions between companies and the customers they serve, again permitting the practice within certain reasonable limits. The difference: This agency is the Securities and Exchange Commission, which, along with the US Food and Drug Administration (FDA), oversees one of the most stringent and complex regulatory areas in the entire US economy. ...
  • Could FTC's New Social Media Guidance be Similar to one Pending at FDA?

    If pharmaceutical and medical device companies are eagerly awaiting the US Food and Drug Administration's (FDA) social media guidance for promoting their products using social networks like Twitter and Facebook, a new guidance released by the US Federal Trade Commission (FTC) may provide some insight into how the agency will treat mobile and social advertising. Background: Authority FTC and FDA operate under a slightly unusual agreement in which FTC voluntarily cedes so...
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    Regulatory Experts Urge Caution With Communications Activities

    The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...
  • Feature ArticlesFeature Articles

    FDA Regulation of Healthcare Product Advertising on Social Media

    Social media offers exciting new approaches to marketing products, but the medical products industry has been slow to participate. Social media communications can be daunting for many reasons: it is public, continuous, interactive and global, and there are often extreme space limitations. Many in the medical device industry point to a lack of US Food and Drug Administration (FDA) guidance 1 as one of the main reasons for caution. In a survey by Massachusetts trade asso...
  • Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

    The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical industry, including advertising through social media channels, according to a 10 October posting in the Federal Register . "FDA has an interest in determining the attitudes, perceptions, and opinions of healthcare professionals with prescribing authority regarding such...
  • FDA Guidance Establishes Specific Recommendations for Ear Infection Therapies

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to assist sponsors developing therapies to treat bacterial ear infections. The guidance, Acute Bacterial Otitis Media (ABOM): Developing Drugs for Treatment , finalizes the draft version of the same guidance, which was released in January 2008, and revised a 1998 guidance by a similar name. "This guidance focuses on specific drug development and trial design issues that are un...
  • Clock Starts Ticking on Issuance of FDA's Social Media Guidance

    The end is near-for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is. Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014. "Not later than 2 years aft...
  • New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance

    A new program announced by the US Food and Drug Administration aims to strengthen global regulatory capacity by working with the World Health Organization (WHO) to support new, innovative approaches to clinical trial designs for vaccine products and postmarketing pharmacovigilance. "Adequate regulatory oversight throughout the vaccine development life cycle is essential in assuring the safety, purity, and potency of vaccines and other biological," said FDA's Center for B...
  • Brazil: House Holds Hearing on Breast Implants

    The Commission on Social Security and Family of the House of Representatives held on 19 April 2012 a public hearing to discuss the situation of Brazilian women with silicone breast implants made by now-defunct French manufacturer Poly Implant Prothese and Dutch manufacturer Rofil.  ANVISA's Chief Executive Officer, Dirceu Barbano, noted his agency had inspected two manufacturers and that by the end of this year all manufacturing plants with valid registration woul...