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  • FDA Moves to Close Glaring Loophole in Current Drug Import System

    A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law. Background: Import Regulation The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Section 801(b) of the FD&C Act , FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Sect...
  • Time for Generic Pharma Companies to Re-Identify Themselves, FDA Says

    The US Food and Drug Administration (FDA) is reminding all manufacturers of generic drug products, including active pharmaceutical ingredients used in generic drug manufacturing, that they need to re-register with the agency under the terms of a 2012 law. Background In the lead-up to the 2012 passage of  The Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA regulators highlighted a growing problem: Many generic drug manufacturers were moving the...
  • New Patient-Focused Drug Development Meeting to Concentrate on Neurologic Disorders

    Since the passage of the  Food and Drug Administration Safety and Innovation Act (FDASIA)  in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process. Now the agency is gearing up for its eighth meeting for patients with neurologic manifestations of inborn errors of ...
  • FDA, ONC Issue Long-Awaited Health IT Framework

    The US Food and Drug Administration (FDA) has released for consultation a new proposed framework on how to regulate health information technology (IT), including mobile medical device applications ("apps") according to risk. Background Mobile medical applications can best be understood as programs run on a mobile device such as a smartphone or tablet that allow a user to access a medical technology wherever and whenever they wish. For example, a smartphone application t...
  • FDA Proposes Making it Easier to Classify and Reclassify Medical Devices According to Risk

    A new regulation proposed today by the US Food and Drug Administration (FDA) would change the procedures by which it classifies and reclassifies medical devices according to their perceived risk, making it much easier for FDA to make changes based on new or changing information. Background The proposed regulation was called for by a 2012 law known as the Food and Drug Administration Safety and Innovation Act (FDASIA) . Section 608 of the law called for FDA to be give...
  • FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

    US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...
  • Can FDA and Industry Give Patients and Providers the Evidence They Need to Make Informed Decisions?

    The US Food and Drug Administration (FDA) soon plans to hold a hearing on the extent to which historically under-represented subgroups of patients are included in clinical trials, and whether their lack of inclusion may have implications for the efficacy and safety of products given to those patients. Background When the  Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The sect...
  • In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain 'Mostly Unchanged'

    The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process-also known as the 510(k) clearance process-saying that it intends to largely leave its existing 1997 guidance document as-is. Background In 2011, FDA released a new guidance document,  510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Devic...
  • FDA Says Many Social Media Guidances on the Way, but Claims FDASIA Deadline has Already Been Met

    For years, members of the pharmaceutical industry have awaited the release of what has been dubbed by many as "The Social Media Guidance," a document intended to explain in full detail how companies could use social media platforms to advertise and promote their products while meeting the US Food and Drug Administration's (FDA) strict regulatory requirements. There's just one problem, according to FDA officials: There is no single social media guidance in development. ...
  • House Legislators Set to Grill FDA on FDASIA Progress

    It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing? Background: FDASIA's User Fee Provisions FDASIA , passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms. To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescripti...
  • Rare Disease Advocate Slams FDA Expedited Approval Guidance

    An advocacy group focused on the needs of patients with rare diseases is pressing the US Food and Drug Administration (FDA) to consider the needs of such patients when developing guidance on expedited approval pathways, and getting some major congressional support in the process. Background The Food and Drug Administration Safety and Innovation Act ( FDASIA ) was passed into law in the summer of 2012, and contained a plethora of provisions intended to both bette...
  • Fifth Patient-Focused Drug Development Meeting to Cover Fibromyalgia

    The US Food and Drug Administration (FDA) has announced that it will soon hold its fifth meeting under its patient-focused drug development program, created last year to seek out opinions from patients in 20 different disease areas over the next five years. Background The program was the brainchild of disease advocate groups, which convinced legislators to include it in the Food and Drug Administration Safety and Innovation Act of 2012 ( FDASIA) . Under Section X of t...