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  • RAPS' LatestRAPS' Latest

    When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS

    When about 60 Pfizer employees convened last November at the company’s New York headquarters for a customized on-site, two-day training session, one of the key goals was establishing a common language. Attendees represented several groups with different, but related, roles within the company. Some were part of a pilot program of “core strategists,” a new role combining expertise in regulatory and chemistry, manufacturing and controls (CMC). Another group was made up...
  • Regulatory NewsRegulatory News

    EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms

    The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies. The plan seeks to support such companies through all stages of drug development and to further engage with sectors adjacent to pharmaceuticals (e.g. companion diagnostic technologies, medical technologies industries and digital health) in light of Europe’s new medical device legislation , advances in pharmaco...
  • Regulatory NewsRegulatory News

    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
  • Regulatory NewsRegulatory News

    FDA Willing to Accept Different Endpoints When Assessing Lung Cancer Drugs

    Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week. The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics , is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC d...
  • Regulatory NewsRegulatory News

    EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections

    A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific advice are more likely to get their products authorized . Background EMA provides scientific advice to companies for a fee in order to assist them in designing clinical trials through its Scientific Advice Working Party (SAWP). If a clinical trial is not well designed, it can be difficult to for the agency to conduct an assessment of the product a...
  • Regulatory NewsRegulatory News

    Citing Safety Risks, FDA Adopts New Standards for Small-Bore Connectors

    Even small devices can cause big problems. That's the conclusion of a new guidance document issued this week by the US Food and Drug Administration (FDA), which is trying to make "small-bore connectors" safer. Background The devices—technically a medical device—are used to temporarily connect two otherwise incompatible medical devices, FDA explains in its final guidance document, Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors I...
  • Regulatory NewsRegulatory News

    EMA Boasts Success of Tools for Small- and Medium-Sized Companies

    The European Medicines Agency (EMA) says that its tools designed to aid micro-, small- and medium-sized enterprises (SMEs) have increased those companies’ success in obtaining authorization for their products. The agency released a report this week highlighting the growth and success of the program. Background The European Commission (EC) found that a number of hurdles, including procedural and financial steps involved in obtaining marketing authorization, heavily aff...
  • FDA Issues Guidance on Qualifying for Device User Fee Exemptions, Reductions

    Last week, the US Food and Drug Administration (FDA) released all of the updated user fees various regulated industries will need to pay to the agency in the coming 2014 fiscal year, including special exemptions for some medical device companies. Now FDA is out with a new guidance document meant to explain exactly which medical device companies are eligible for reduced rates, and how to determine eligibility. Background Since the Medical Device User Fee Act (MDUFA) ...
  • FDA Releases Draft Guidance on 510(k) Submissions

    The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted through a 510(k) application. The 26 July document, Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications , specif...
  • FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

    The US Food and Drug Administration (FDA) has released new guidance on how small medical device companies can qualify as an FDA-approved small business and be eligible to pay reduced fees under the Medical Device User Fee Act (MDUFA) . FDA's Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification  notes small businesses are authorized to pay "substantially reduced" fees under t...
  • Brazil: New IVD Guidance Aims to Assist Small Businesses

    A new guidance manual for the in vitro diagnostic (IVD) business sector is intended to assist companies in how to obtain the right to market their products in Brazil.  The Manual was developed by Brazil's national regulatory agency, Anvisa, in collaboration with the Brazilian Agency for Industrial Development (ABDI) and the Agency for Support to Entrepreneurship and Small Business (Sebrae).  The collaborative effort is especially intended to assist local com...
  • Indian Parliamentary Report Says Clinical Trials Not Being Conducted Properly

    A scathing report from the Parliament of India's Standing Committee on Health and Family Welfare (SCHFW) indicates pharmaceutical companies in the country are increasingly moving their clinical trials to smaller cities, potentially risking future patients' safety by enrolling less-representative sample populations, reports The Economic Times . The Times notes pharmaceutical companies have traditionally conducted their clinical trials in larger population centers, whic...