• Regulatory NewsRegulatory News

    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

    A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products. Background The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ven...
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    EMA Releases Draft Guides to Reduce and Report Medication Errors

    To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors. Medication errors are mistakes made when prescribing, dispensing and administering medicine. The agency says these errors are the "most common preventable cause of undesired harmful effects" related to medicine in the EU. According to EMA, these errors have...
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    To Boost Transparency, Canada Launches GMP Inspection Database

    Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015. The new Drug and Health Product Inspection Database will allow Canadians to search for timely information on good manufacturing practice (GMP) inspections conducted by Health Canada. Background The database is part of a larger effort by Health Canada to improve transparency after being called out publicly by The Toront...
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    EU Makes Major Update to Drug Manufacturing Guidelines

    For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation . The update to EurdraLex Volume 4, Annex 15: Qualification and Validation goes into effect on 1 October 2015. The new version accounts for significant changes in the regulatory environment and will align with guidelines from the International Conference on Harmonisation (ICH). Background Annex 15 contains the requirements for qua...
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    FDA Finalizes Lot Distribution Report Guidance With Few Changes

    New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed. Background As required by  21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted...
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    Health Canada to Increase GMP Inspections, Promises Greater Transparency

    Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future. The move comes in the wake of an ongoing investigation by The Toronto Star , which has uncovered cases of data manipulation and unreported side effects at manufacturers supplying products to Canada. The paper made these revelations after obtaining inspection reports from the US Food and Drug Administration...
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    FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

    US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards. On Thursday, 22 January 2015 the US Food and Drug Administration (FDA) issued an update to its Import Alert 66-40, which is used to warn US customs officials that a company's products have not met good manufacturing practices (GM...
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    China Adopts Milestone Device Good Supply Practices

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices. The GSP regulatio...
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    Anvisa Updates BA, BE Test Best Practices Certification

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
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    What’s In a Name? The Value of Pharmaceutical & Biologic Branding

    September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch-Waxman strove to offer consumers the benefits of “rapid availability of lower-priced generic versions of innovator drugs” 1 while preserving a meaningful period of market exclusivity for innovators to recoup their costs. In the process, however, Hatch-Waxman established conditions that fundamental...