• Regulatory NewsRegulatory News

    Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days ), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device. The draft comes as the controversy over Mylan’s EpiPen has simmered down, though the only current gener...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on New Pre-Request for Designation Process

    After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests. Specifically, this program, referred to as pre-request for designation (pre-RFD) program, allows sponsors to ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the age...
  • Regulatory NewsRegulatory News

    FDA Offers Final Guidance on CGMP Requirements for Combo Products

    The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013. The guidance addresses general considerations for CGMP requirements for these drug-drug, drug-device, drug-biologic or biologic-device combination products and the purpose and content of specific provisions from 21 CFR part 4 . The guidance also discus...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
  • Feature ArticlesFeature Articles

    Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

    This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry. Why IDMP? Despite clear progress in the development of increasingly specific and complex drugs, health authorities worldwide say they have observed a steady and alarming increase in ...
  • Regulatory NewsRegulatory News

    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Starts Review of Drug Recall Guidelines The Drugs Consultative Committee (DCC) of India has committed to reviewing the guidelines on drug recalls to ensure substandard products are effectively removed from the market. Officials want to make manufacturers monitor the quality of drugs in the supply chain and hold them responsible for voluntarily recalling products that ...
  • Regulatory NewsRegulatory News

    Health Canada Looks to Raise the Bar for Regulating Natural Health Products

    A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs. The proposal, unveiled in late September, would cover the three buckets of health products and group them together as part of new regulations for “self-care products,” which is part of the regulator’s wider effort to refocus the approval of health claims based on sc...
  • Regulatory NewsRegulatory News

    FDA Establishes New Process for Preliminary Combination Product Classification

    Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated. Combination Products Combination products are products that combine two or more different types of FDA-regulated products, including drugs, biologics and medical devices. However, when it comes to reviewing such products, FDA makes a determination as to how the product will be classif...
  • Regulatory NewsRegulatory News

    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
  • Regulatory NewsRegulatory News

    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
  • Regulatory NewsRegulatory News

    Swedish Regulators Find Capsugel’s Oregon Site Not GMP Compliant

    Sweden’s Medical Products Agency (MPA) declared Monday that Capsugel subsidiary Bend Research’s Oregon manufacturing site does not comply with Europe’s good manufacturing practice (GMP) requirements. The statement of non-compliance follows a 24 February inspection of the site, which uncovered non-compliant operations with regard to non-sterile products, packaging and quality control testing. The inspection also found two critical, seven major and 12 other deficiencies ...