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  • Regulatory NewsRegulatory News

    New California Laws Set Sights on Pay-for-Delay Agreements, HIV Prevention

    California Gov. Gavin Newsom (D) on Monday signed into law one bill that aims to crack down on pay-for-delay deals that can block the launch of generic drug competition and one bill that will allow pharmacists, under specific circumstances, to distribute limited supplies of HIV drugs without prescriptions. California’s new pay-for-delay law is the first in the nation directed at the deals between pharmaceutical companies in which one company pays a competitor to delay r...
  • RoundupsRoundups

    Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Analysis of Paclitaxel-Coated Device Data Finds no Safety Signal   The Therapeutic Goods Administration (TGA) has analyzed Australian adverse event data on patients with paclitaxel-coated devices in light of a meta-analysis published last year. The meta-analysis found a link between the devices and increased risk of death, but no safety signal was seen in the TGA...
  • Regulatory NewsRegulatory News

    FDA Warns Mylan Over Quality System Failures

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 3 April to Mylan Pharmaceuticals for its Nashik, India-based manufacturing site, which FDA said does not have a functioning quality system. "Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," FDA said following a nine-day inspection in September 2016. The manufacturing site is ...
  • Regulatory NewsRegulatory News

    Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics

    The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos. The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member...
  • Regulatory NewsRegulatory News

    French Biotech’s Manufacturing Operations Suspended by ANSM

    France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November. ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The comp...
  • Regulatory NewsRegulatory News

    NGS Altering the Landscape of Antiviral Drug Resistance Analysis, FDA Officials Say

    As next-generation sequencing (NGS) costs gradually decline, the Food and Drug Administration’s (FDA) Division of Antiviral Products (DAVP) anticipates that more companies will make the switch to NGS for future antiviral drug resistance analyses and other additional uses. The push to more NGS use comes as DAVP independently assessed NGS resistance data for three new drug applications (NDAs), which taught the agency a few important lessons and will help it prepare for the...
  • Regulatory NewsRegulatory News

    FDA Finalizes HIV Drug Development Guidance

    The US Food and Drug Administration (FDA) has added more detailed definitions for treatment-naïve and treatment-experienced HIV patients and provides recommendations for designing switch trials, according to guidance finalized Monday. The agency hopes the guidance will "promote and facilitate more drug development in the heavily treatment-experienced population," an FDA spokesman told Focus , by introducing a trial design using "an endpoint of virologic efficacy within ...
  • Regulatory NewsRegulatory News

    HHS Establishes Organ Donation Policy for Patients With HIV

    The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...
  • Regulatory NewsRegulatory News

    Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs

    The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, and transferred its authority to an existing advisory committee with a new name, the agency announced this week. In a 19 March 2015 posting in the Federal Register , the government's daily record of agency actions, FDA said it was immediately disbanding the committee as it "is no longer needed." ...
  • Regulatory NewsRegulatory News

    New FDA Guidance Explains Approval Process for HIV Prevention Products

    New final guidance issued this week by the US Food and Drug Administration (FDA) is meant to clarify the development pathway for vaginal microbicides intended to prevent the transmission of the human immunodeficiency virus (HIV). Background The guidance document, Vaginal Microbicides: Development for the Prevention of HIV Infection , follows years of increasing interest in developing products which could supplement or even replace condoms in preventing the transmissi...
  • Regulatory NewsRegulatory News

    Australian Regulators Lift Ban on HIV Self-Test Kits

    Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...
  • Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

    The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine). Background The legal victory for AHF is its second in the last year. In 2013, FDA announced it would expedite the review of Truvada based on its expected cl...