RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    Convalescent Plasma: FDA Facilitating Emergency Access

    One potential treatment for COVID-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease, and the US Food and Drug Administration (FDA) said Tuesday that it will help to provide access to it for patients with serious or immediately life-threatening COVID-19 infections. The idea behind the treatment is that plasma collected from patients recovering from COVID-19 may contain antibodies to the virus that might be effectiv...
  • Regulatory NewsRegulatory News

    Gilead’s Orphan Drug Designation for COVID-19 Antiviral Raises Questions

    As Gilead begins to streamline the process for COVID-19 patients to receive its experimental antiviral remdesivir on a wider basis, the company also raised some eyebrows on Monday by obtaining an orphan drug designation for the potential COVID-19 treatment. Orphan designations are meant to help companies developing treatments for limited populations (less than 200,000 people) and they provide incentives like tax credits for research and seven years of exclusivity for ...
  • Regulatory NewsRegulatory News

    BPCIA Turns 10: Nearly 100 Drugs Become Biologics

    The law that opened up the approval pathway for biosimilars, known as the Biologics Price Competition and Innovation Act (BPCIA), turned 10 years old on Monday and nearly 100 drugs officially became biologics under what’s known as the “deemed to be a license” provision of the BPCIA. As anticipated , the shift for these nearly 100 products will mean insulin and treatments for respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, ...
  • Regulatory NewsRegulatory News

    Gilead Pauses Compassionate Use of Experimental Antiviral for COVID-19

    Biopharma company Gilead said Sunday that it would temporarily pause allowing the use of the potential COVID-19 treatment remdesivir outside of clinical trials as the company looks to ramp up wider use of the antiviral following discussions with regulators worldwide. Formerly a potential Ebola treatment, remdesivir is an experimental, intravenous antiviral and is  in five clinical trials  in the US and China to treat COVID-19. According to FDA, remdesivir has been used ...
  • Regulatory NewsRegulatory News

    Hungarian Notified Body is 12th to be Designated Under MDR

    Hungary’s CE Certiso Orvos-és Kórháztechnikai Ellenőrző és Tanúsító Kft. has been designated as the 12 th notified body under the EU’s incoming medical devices regulation (MDR) on Friday. The Hungarian notified body is also designated under the EU’s medical devices directive (MDD), the active implantable devices directive and the in vitro diagnostics directive. Since the beginning of 2020, CE Certiso is just the third notified body to be designated and listed in the ...
  • Regulatory NewsRegulatory News

    FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment

    In light of the need to act quickly and efficiently to respond to the COVID-19 public health emergency, the US Food and Drug Administration (FDA) on Friday said that it anticipates that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidance documents. Although COVID-19-related guidance documents will be immediately implemented without prior public comment, FDA said it will still solicit comment, review all comments...
  • Regulatory NewsRegulatory News

    FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic

    The US Food and Drug Administration (FDA) released guidance on Friday saying it does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring during the pandemic. Examples of possible modifications include the inclusion of monitoring statements related to patients with COVID-19 or co-existing conditions (e.g., hyperten...
  • Regulatory NewsRegulatory News

    EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic

    The European Commission, European Medicines Agency (EMA) and the Head of Medicines Agencies on Friday released guidance for biopharma companies that may need to adjust their clinical trials during the COVID-19 pandemic. Similar to guidance issued by the US Food and Drug Administration on Wednesday, the EMA’s 8-page guidance discusses how to deal with the extraordinary situations that the pandemic presents. It also includes specific advice on trials for COVID-19 treatm...
  • Regulatory NewsRegulatory News

    MHRA Seeks Info on Drug Supply Issues Related to COVID-19

    To help manage the UK supply of medicines, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday reminded marketing authorization holders (MAHs) that they need to provide information about any supply issues they are experiencing as a result of COVID-19. MAHs should focus on the entire supply chain of the active substance and medicinal product, including manufacturing sites of the starting materials and packaging materials for the medicinal prod...
  • Regulatory NewsRegulatory News

    House Oversight Chair Probes Lack of Coronavirus Tests

    As the Trump Administration “has repeatedly failed to meet its goals for coronavirus testing,” Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, and other subcommittee chairs are seeking answers in a letter Thursday to HHS Secretary Alex Azar and CDC Director Robert Redfield. While noting that a previous request earlier this month for information on plans to ramp up testing have gone unanswered, the representatives say that “it has ...
  • Regulatory NewsRegulatory News

    FDA Looks to Speed Access to Potential COVID-19 Treatments

    With the potential for a coronavirus vaccine likely more than a year away, the US Food and Drug Administration (FDA) is doing what it can to speed access to potential COVID-19 treatments, President Donald Trump said in a press conference alongside FDA Commissioner Stephen Hahn on Thursday. Specifically, Trump discussed one treatment that already has FDA approval, chloroquine, first approved as a malaria treatment more than 50 years ago, as well as another potential trea...
  • Regulatory NewsRegulatory News

    FDA Halts Domestic Surveillance Inspections

    The US Food and Drug Administration (FDA) said Wednesday that it has temporarily postponed all domestic routine surveillance facility inspections. The decision, which FDA said is for "the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors" follows an attempt by an FDA official to inspect a contract development and manufacturing organization (CDMO) on Monda...