RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Pediatric Information in Drug Labels

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.   “The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is c...
  • Regulatory NewsRegulatory News

    FDA Offers Recommendations on Highlights Section of Labeling

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics. Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised. In 2006, FDA's final rule on the conten...
  • Regulatory NewsRegulatory News

    FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers

    The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA). Thanks to the recently reauthorized Generic Drug User Fee Amendments (GDUFA II), FDA will issue Deficiency Review Letters (DRLs) and information requests (IRs) to obtain further information ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Bans Transvaginal Mesh Products Following Risk-Benefit Review Australia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits. Patients and healthcare experts around the world have questi...
  • Regulatory NewsRegulatory News

    Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements

    Industry and pharmacy groups generally support the US Food and Drug Administration's (FDA) proposal to limit the amount of risk information presented in pharmaceutical direct-to-consumer (DTC) advertisements, though others have criticized the plan and research backing it as flawed. Background In August, FDA proposed a new approach to presenting risk information in DTC television and radio ads that would allow drugmakers to limit the amount of risks presented. Cu...
  • Regulatory NewsRegulatory News

    De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014

    Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance. The draft and final guidance come as FDA has seen an increased De Novo submission volume, from 42 submissions in 2014 to 69 in 2017. The draft guidance, when finalized...
  • Regulatory NewsRegulatory News

    FDA Holds First Patient Engagement Advisory Committee Meeting

    The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices. The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients. Patient Engagement at FDA FDA ...
  • Feature ArticlesFeature Articles

    New Developments in Payor Communications: Are 20 Years of Uncertainty Over?

    This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance. Introduction In...
  • Regulatory NewsRegulatory News

    FDA Finalizes Combination Product Classification Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices. The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act , and details how F...
  • Regulatory NewsRegulatory News

    ABPI Extends Astellas UK Suspension for 12 More Months

    The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety." Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, inc...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Reveals Talks With FDA About Joint Accelerated Assessment Activities The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation. EMA ha...
  • Regulatory NewsRegulatory News

    Cybersecurity: House Committee Looks to Build on Public-Private Partnerships

    The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...