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  • Regulatory NewsRegulatory News

    FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements. FDA said the differences between the draft from May 2013 and the final guidance focus on areas that needed to be clarified. “In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends Ban of US CMO’s Medicines

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) should no longer be available in the EU, except for Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health. The recommendation follows a good manufacturing practice (GMP) review afte...
  • Regulatory NewsRegulatory News

    Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

    Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak. The recall is an expansion of an earlier recall dated 15 July 2016, in which PharmaTech said it was recalling all lots of Diocto Liquid (docusate sodium), a stool softener, distributed by Rugby Laboratories after the com...
  • Regulatory NewsRegulatory News

    Professors Call on Congress to Make More Info Public on Generic Manufacturers

    As discussions over the reauthorization of the Generic Drug User Fee Amendments (GDUFA) continue, two professors from MIT and the University of Chicago are calling on Congress to require the Food and Drug Administration (FDA) to be more transparent about the companies that manufacture generic drugs. The call for more clarity from Rena Conti, assistant professor of Health Policy at The University of Chicago, and Ernst Berndt, a professor of Applied Economics at the MIT Sl...
  • Regulatory NewsRegulatory News

    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
  • Regulatory NewsRegulatory News

    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
  • Regulatory NewsRegulatory News

    With $5 Million Grant, FDA Wants to Change how the US Responds to Future Public Health Emergencies

    A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola. Background "In emergency situations, rapid response is critical," FDA writes on its website. And while that response often includes basic provisions—money to buy supplies and the deployment of healthcare providers to an area, for example—it almost always includes medical products like dru...
  • Regulatory NewsRegulatory News

    FDA to Spend $16M to Track National Prescribing Trends

    The US Food and Drug Administration (FDA) is preparing to put more than $16 million into a multi-year program intended to provide regulators with data on how US patients are prescribed drug products. The data, including medical claims data, is meant to provide regulators with the ability to see which drugs are being used by patients, for how long and with what other drugs. Regulators are also looking to pair that data up with basic demographic data on patients, such as a...
  • Regulatory NewsRegulatory News

    FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

    A multi-year, $26 million program launched last year by the US Food and Drug Administration (FDA) is now being partially shelved after running into significant difficulties, FDA sources tell Focus . Background The program, known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI or PDLI-EI) began in February 2013 when FDA announced its creation in the Federal Register and solicited public feedback on its goals. Simply put, the program i...
  • FDA Looks to Surge Approach to Complete DESI Reviews

    In the US, as many as several thousand drugs are currently marketed without ever having received approval from the US Food and Drug Administration (FDA) as being effective for their intended purpose. While many of these drugs are simply illegal, there are others that remain on the market legally despite never having received approval. The History of Pharmaceutical Law in the US To understand why is to understand the evolving history of federal pharmaceutical law in t...
  • FDA Seeks to Broaden Collection of Prescribing Data in Bid to Track Use, Safety of Drugs

    US regulators are laying the groundwork to potentially monitor the use of drugs by patients discharged by healthcare facilities, mirroring and expanding upon other planned activities. Background In June 2013, the US Food and Drug Administration (FDA) announced that it was seeking access to data on adult and pediatric utilization of drugs used in inpatient and emergency settings. The intent, FDA said, was to better conduct postmarket surveillance on the safety of phar...
  • Shaking Off Prior Criticism, FDA Forges Ahead with Additional Social Media Monitoring Plans

    The US Food and Drug Administration (FDA) recently issued a notice indicating that it is seeking the services of a company to help it monitor online sentiment, keep abreast of social media conversations and even determine "influencers" to better target its outreach. The FDA " Sources Sought " notice was posted on 23 December 2013 to the government's Federal Business Opportunities (FBO) website. Existing Plans It is similar in many respects to an earlier contract a...