The main RAPS website will offline for several minutes at 5 PM on 22 October 2021 due to scheduled maintenance.
We apologize for any inconvenience during this time.

  • Regulatory NewsRegulatory News

    New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities

    The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. The safety of compounded drugs has been a high profile issue for FDA since 64 people were killed by a fungal meningitis outbreak tied to the New England Compounding Center , a Massachusetts-based compounder, in 2012. Since then, both Congress and FDA have taken steps to improve the safety of compounded ...
  • Regulatory NewsRegulatory News

    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
  • Regulatory NewsRegulatory News

    FDA Lowers ANDA Fee Rates for 2017

    Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016. For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016 ), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in ...
  • Regulatory NewsRegulatory News

    Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US

    The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 ( GDUFA ). The companies include China’s Jiangsu ZW Pharmaceuticals Co. Ltd., which received a warning letter in 2015, and Wuxi Kaili Pharmaceutical Company, whi...
  • Regulatory NewsRegulatory News

    Biosimilar User Fees: FDA and Industry Reach Agreement

    The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...
  • Regulatory NewsRegulatory News

    Understaffed and Underfunded: FDA Begins to Hear Opinions on Crafting an OTC Drug User Fee Program

    With only 18 full-time employees working to oversee an over-the-counter (OTC) drug monograph program covering hundreds of thousands of products, the US Food and Drug Administration (FDA) is beginning to evaluate different perspectives on creating a new user fee program to help, particularly as congressional appropriations have remained stagnant over the past few years. On Friday, FDA held a public meeting on the idea of creating this user fee program for OTC drugs, with ...
  • Regulatory NewsRegulatory News

    FDA Outlines Medical Device Real-World Evidence User Fee Proposal

    Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE). The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III. In a meeting on 25 April (the meeting ...
  • Regulatory NewsRegulatory News

    FDA Considers New User Fee Program for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. User fee programs (such as PDUFA , GDUFA , BsUFA and MDUFA , all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of...
  • Regulatory NewsRegulatory News

    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
  • Regulatory NewsRegulatory News

    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • Regulatory NewsRegulatory News

    FDA's CDRH Adds New Online Tools to Help Industry Learn the Ropes

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released seven new modules of online information this week designed to help industry understand the various parts of medical device laws, regulations and policies. The multimedia catalog of online educational modules, known as CDRH Learn, has now grown to over 80 educational modules, which include presentations, printable slides and transcripts. FDA began releasing...
  • Regulatory NewsRegulatory News

    Generic Drug Companies Call for Fixes to GDUFA, Citing Few Returns on Investment

    Several of the generic drug industry's most prominent groups are calling on the US Food and Drug Administration (FDA) to make major changes to the program supporting one of its marquee funding sources, the Generic Drug User Fee Act (GDUFA). Background GDUFA is modeled off several other conceptually similar user fee programs, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). The concept behind the programs is relatively st...