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

 
  • Regulatory NewsRegulatory News

    Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

    Industry cautioned the special 510(k) program expansion proposal could yield the opposite of its intended goal and further limit eligibility of changes that undergo special 510(k) reviews. The main concern among several device companies, including Thermo Fisher Scientific, Cook Group and Fresenius Kabi USA, relates to a lack of clarity around the process used by agency staff to determine whether a submitted special 510(k) will be converted to a traditional 510(k) prior ...
  • Regulatory NewsRegulatory News

    FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

    The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types. Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said...
  • Regulatory NewsRegulatory News

    CDRH Redrafts Policies on CLIA Waivers for IVDs

    The US Food and Drug Administration (FDA) reissued two draft guidances on Wednesday to help in vitro diagnostic (IVD) manufacturers apply for and obtain Clinical Laboratory Improvement Amendments (CLIA) waivers. The newly drafted guidance documents—first issued last November—were updated to reflect input from the comment period that closed after an extension granted per the request of the Coalition for CLIA Waiver Reform earlier this year. Modifications to the 2017...
  • Regulatory NewsRegulatory News

    FDA Clarifies Policies on Dried Plasma Products for Blood Transfusions

    In draft guidance issued Monday, the US Food and Drug Administration (FDA) offered new recommendations to aid in the development of dried plasma products for blood transfusions.   The recommendations are intended to help increase the availability of and access to dried plasma, with policy clarifications ranging from optimal sources of input plasma to submissions for devices used to manufacturer these products. Considerations for manufacturing and product quality as wel...
  • Regulatory NewsRegulatory News

    FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

    The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation.   The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019. FDA is asking interested parties to submit their comments on the guideli...
  • Regulatory NewsRegulatory News

    Verification Systems: FDA Drafts Guidance on What to Include

    To help companies understand the US Food and Drug Administration’s (FDA) recommendations for a verification system that can determine, quarantine and investigate suspect or illegitimate products, FDA on Wednesday issued new draft guidance. The 11-page draft guidance describes FDA’s interpretation of the requirements of section 582 of the Food Drug and Cosmetic (FD&C), which set forth verification requirements that took effect on 1 January 2015 for manufacturers, whole...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program   The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance inspections and prioritize the assessment of companies that introduce new drugs to the marke...
  • Regulatory NewsRegulatory News

    FDA Unveils Plan for CDER Draft Guidance in 2018

    The plan for 2018 draft guidance documents from the US Food and Drug Administration (FDA) includes more than 10 in three top categories, including FDA procedures, pharmaceutical quality/chemistry, manufacturing and controls (CMC) and clinical/medical. Several notable draft guidance documents coming this year in the clinical/medical category include: "Early Alzheimer’s Disease: Developing Drugs for Treatment," "Amyotrophic Lateral Sclerosis: Developing Drugs for Treat...
  • Regulatory NewsRegulatory News

    EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

    The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA). "Currently, several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach," the guideline said. "Despite significant advances in...
  • Regulatory NewsRegulatory News

    Hormonal Contraceptive Labeling: FDA Issues Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued new draft guidance providing labeling recommendations for hormonal contraceptives in line with requirements from the agency's 2006 physician labeling rule (PLR) and 2014 pregnancy and lactation labeling rule (PLLR). FDA had previously issued draft guidance on combined oral contraceptive (COC) labeling in 2004, but withdrew the guidance in 2015. However, FDA says it took comments submitted to the 2004 draft gui...
  • Regulatory NewsRegulatory News

    CMC Changes for Biologics: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general...
  • Regulatory NewsRegulatory News

    Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

    Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force expressed disappointment that, although it participated in the Generic Drug User Fee Amendments (GDUFA II) negotiation...