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  • Regulatory NewsRegulatory News

    N-Nitrosamine impurities: FDA issues detection, prevention guidance

    An immediately effective guidance from the US Food and Drug Administration (FDA) details steps to be taken to detect and prevent the introduction of potentially carcinogenic nitrosamine impurities into finished drug products and active pharmaceutical ingredients.   “The recent unexpected finding of nitrosamine impurities, many of which are probable or possible human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, metformin, rifam...
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    FDA warns Mylan, Acella Pharmaceuticals over GMP violations

    The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.   Mylan Laboratories   FDA’s warning letter to Mylan comes after the agency inspected the company’s facility in the Sangareddy District of Telangana, India over the course of a week last February.   The warning letter, which cites the company for issues related to its cleaning procedures and handling of r...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug...
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    FDA addresses nitrosamines in TB drugs

    Nitrosamine impurities have now been found in two tuberculosis drugs, prompting the US Food and Drug Administration (FDA) to clarify how it will handle elevated levels of the potential carcinogen in life-saving antibiotics.   Both rifampin and rifapentine are antibiotics used to treat tuberculosis, and rifampin is also used to treat other serious bacterial infections. Elevated levels of nitrosamines have been found in samples of both substances: the nitrosamine 1-methy...
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    FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.   FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.   "There are few effectiv...
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    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • ReconRecon

    Recon: Drugmakers counter Trump's pricing plan; Teva indicted by US DOJ on price-fixing charges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers deliver counteroffer to Trump international pricing plan ( Politico ) Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide ( Pink Sheet ) Eric Topol Criticizes FDA's Exaggeration Of Plasma's Efficacy In COVID-19 Treatment ( NPR ) Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy ( KHN ) O...
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    Study: FDA details high global drug quality

      A quality improvement study led by the US Food and Drug Administration (FDA) found that over 200 difficult-to-manufacture drug product samples met US standards for dosage unit uniformity and dissolution.   The 252 products that were sampled in the largest such study to date included 35 innovator and 217 generic drug samples. In all, the products contained 17 different active pharmaceutical ingredients (APIs) and the samples originated from 46 firms.   Adam Fish...
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    Health Canada adopts ICH pediatric drug development guidance

    Health Canada is implementing a guidance for nonclinical safety testing to support pediatric medication development.   The guidance was developed by the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), and carries the title Guidance S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines . The Canadian guidance is being fully implemented without modifications, a commitment Health Canad...
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    FDA issues pandemic inspections FAQ guidance

    The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance  explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.   Inspections   For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval an...
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    US sues Teva over Copaxone co-pay assistance scheme

    The US Department of Justice (DOJ) on Tuesday announced it has filed a False Claims Act complaint against Teva Pharmaceuticals USA and Teva Neuroscience, alleging the company violated anti-kickback rules by coordinating with two patient assistance charities and a specialty pharmacy to cover Medicare co-pays for its multiple sclerosis drug Copaxone (glatiramer acetate).   “The government’s complaint today alleges that Teva used ostensibly independent charitable founda...
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    FDA trims reserve testing quantity requirements

    Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for bioavailability and bioequivalence testing, generally reducing the amount of drug product that applicants must retain.   An interim rule issued in 1990 and made final in 1993 required applicants or contract research organizations (CROs) to retain an amount of test article and ...