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  • Regulatory NewsRegulatory News

    Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance

    About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...
  • Regulatory NewsRegulatory News

    FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

    The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of pop...
  • Regulatory NewsRegulatory News

    Experts Call for New Regulatory Pathways for Antibiotics

    Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics. At the FDA/CMS Summit in Washington, DC today, representatives from several companies developing new antibiotic treatments said that while recent initiatives such as the Generating Antibiotics Now Act (GAIN Act) have helped revitalize investment in antibiotic development, more needs to be done to encourage research and deve...
  • Regulatory NewsRegulatory News

    EMA Draft Guidance Seeks to Speed New Antibiotics Development

    The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs. Background Like in the US, the growth of bacteria resistant to a range of antibiotics, along with the need for new antibiotics to treat patients with limited or no treatment options, sp...
  • Regulatory NewsRegulatory News

    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
  • FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing

    The US Food and Drug Administration (FDA) has unveiled a new guidance document on biosimilars, this time explaining how to use clinical pharmacology data to show similarity to a reference product. Background The guidance, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product , is one of several under development by FDA to establish a thorough biosimilar pathway. While the Patient Protection and Affordable Care Act (PPACA) ves...
  • FDA Signs Off on Par Pharma's Bioequivalence Study on Generic Wellbutrin Even as Questions Remain

    The US Food and Drug Administration (FDA) has approved a supplemental Abbreviated New Drug Application (sNDA) sponsored by Par Pharmaceuticals for a 300 mg, extended-release version of the popular antidepressant Wellbutrin XL (bupropion). The approval appears to be the first since the agency formally withdrew a nearly identical drug from the market several months ago after the product was found to not be bioequivalent to the reference listed drug (RLD). Background In Se...
  • A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?

    In March 2013, the US Food and Drug Administration (FDA) formally withdrew approval for Impax Laboratory's buproprion hydrochloride extended release 300 mg (Budeprion XL 300 mg), saying the drug had been found to not be bioequivalent to its reference listed drug, Wellbutrin XL 300 mg. Soon thereafter, the agency announced it was looking for a company to further study the issue of why Impax's drug wasn't bioequivalent when several other generic products did not exhibit sim...
  • Feature ArticlesFeature Articles

    Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

    Human clinical pharmacology, pharmacokinetic (PK) and pharmacodynamic (PD) studies are vital for many reasons, and uniquely useful in extrapolating the efficacy and safety of biosimilars. PK and PD studies are the most objective clinical trials, and are sensitive to changes in a drug product. But the workings and concepts behind such studies are not well understood by many in industry, and even physicians, in comparison with clinical efficacy. This article presents a E...