• Regulatory NewsRegulatory News

    BIO Highlights IP Challenges Around the Globe

    As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products. "These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentabil...
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    ICH Offers Updates on New Members, Progress on Guidelines

    The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday. New members approved at the meeting were Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the US industry group Biotechnology Innovation Organization (BIO) and Korea’s Ministry of Food and Drug Safety (MFDS). In terms of observers, ...
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    FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants

    The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed. "We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close c...
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    Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

    Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs.  So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit int...