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  • Regulatory NewsRegulatory News

    Coronavirus: Will the Outbreak Lead to US Drug Shortages?

    A media report of potential drug shortages because of the ongoing novel coronavirus (COVID-19) outbreak has one senator sending a letter to the US Food and Drug Administration (FDA) seeking answers.   On Sunday, Axios reported that FDA has compiled a list of about 150 drugs that are at risk of shortage because of COVID-19.   In response, Senator Josh Hawley (R-MO) on Monday sent a letter to FDA asking the agency what it is doing to head off any potential short...
  • Regulatory NewsRegulatory News

    Hahn, FDA Center Directors Discuss What’s Necessary to Better Address Rare Diseases

    The US Food and Drug Administration (FDA) on Monday held a public meeting on rare disease product development, and senior leaders provided some perspective on what their respective centers are working on to help those with rare diseases. FDA Commissioner Stephen Hahn opened the afternoon discussions by explaining how important it is to drive rare disease drug development by unleashing the data from very small populations. He addressed the need to integrate more data sou...
  • Regulatory NewsRegulatory News

    Teva Calls on FDA to Make Copaxone a Biologic as Part of March Transition

    Beginning 23 March, the US Food and Drug Administration (FDA) is going to convert more than 100 medicines approved under new drug applications (NDAs) to biologics license applications (BLAs) because the Biologics Price Competition and Innovation Act of 2009 and the recent appropriations law broadened the scope of “biological product” to include any protein, including chemically synthesized polypeptides. Ahead of this switch, FDA published a list of the drugs making t...
  • Regulatory NewsRegulatory News

    FDA Launches Searchable Purple Book

    The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentatio...
  • ReconRecon

    Recon: FDA Approves Esperion Cholesterol Treatment, Lundbeck Migraine Drug; ICER Partners With Aetion for Patient Data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Coronavirus threatens shortages of about 150 drugs ( Axios ) White House to ask Congress for emergency coronavirus funding ( Politico 1 , 2 ) Local Officials in AL, CA Resist Plans to House Coronavirus Patients ( NYTimes ) ( Reuters ) ( NBC ) Companies in pharmaceutical supply chain develop system to track counterfeit drugs ( Reuters ) Gilead Surges After WH...
  • Regulatory NewsRegulatory News

    Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985

    To provide researchers with more accurate and accessible data about historic drug approvals, the US Food and Drug Administration (FDA) on Friday released a dataset containing information about all new drugs and biologics approved by the Center for Drug Evaluation and Research (CDER) dating back to 1985.   “FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug,” FDA writes, addin...
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    FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

    The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requirements is warranted.   The 17-page guidance finalizes a draft version released in July 2019 and replaces the previous final version from January 2019.   Within the guidance, FDA says it will exempt all Type III drug m...
  • ReconRecon

    Recon: Canada Weighs Changes to Drug Pricing Rules; No AdComm for Biomarin’s Valrox

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review ( Fierce ) ( Endpoints ) ( Press ) Stalled Initiatives to Cut Drug Prices Frustrate Trump ( WSJ ) Gilead loses another challenge to a pair of US patents for an HIV prevention pill ( STAT ) ( Endpoints ) Bankrupt antibiotics maker Aradigm turns to old partner/investor for final $3M fire sal...
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    Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

    The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations.   “Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded...
  • Regulatory NewsRegulatory News

    FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

    A month before the long-anticipated transition of applications for certain biological products, including insulin and human growth hormone, to be deemed to be licensed as biologics, the US Food and Drug Administration (FDA) on Thursday issued a final rule amending its definition of “biological product.”   The final rule is one of the last steps in the decade-long transition set in motion by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to deem ap...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: Accord, Glaxo Issue FMD Alerts Over 2D Barcode Problems

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Accord, Glaxo Issue Falsified Medicines Directive Alerts Over 2D Code Problems   Accord Healthcare and Glaxo Wellcome have shared alerts about issues related to compliance with the Falsified Medicines Directive. The alerts are tied to the information encoded on serialised 2D codes.   Glaxo’s situation, which the drugmaker reported to the United Kingdom’s Medicines...
  • ReconRecon

    Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk ( MedtechDive ) Fisher Wallace files citizen petition over FDA’s class III designation for CES ( BioWorld ) AI discovers antibiotics to treat drug-resistant diseases ( Financial Times ) ( STAT ) Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpaye...