• Regulatory NewsRegulatory News

    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
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    EC Report Calls for New Network of Reference Labs for Human Pathogens

    The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday. Currently, many national reference labs for human pathogens have a hard time responding in a coordinated manner to new and emerging infectious threats. The aim of an EU-wide network would be to better respond to cross-border threats, a...
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    Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations

    The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd. The notice was issued following an inspection of Dhanuka's Gurgaon, India facility conducted on 19 February 2016, during which inspectors discovered 32 good manufacturing practice (GMP) violations, including one critical violation involving Dhanuka's "weak" quality ...
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    Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

    Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...
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    EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

    The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...
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    FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US. The warning letter, dated 29 January, reveals how inspectors found “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh, “including actions taken by multiple analysts, on...
  • Indian API Manufacturer Accused of Fabricating Manufacturing, Quality Data

    The US Food and Drug Administration (FDA) has sent yet another letter to an India-based pharmaceutical manufacturer alleging inadequate controls to prevent the falsification of testing data-at least the ninth such letter sent in the last year. Background As Regulatory Focus has previously explained, FDA has been in the midst of a crackdown against deficient manufacturing practices in India, where inspectors have discovered glaring problems and even outright fraud. Si...
  • Prometheus Slams FDA for Lack of REMS Clarity as Agency Shows Signs of Conceding

    A Citizen Petition filed by Prometheus Laboratories in May 2013 slams the US Food and Drug Administration (FDA) for failing to establish "standards and processes" for single shared Risk Evaluation and Mitigation Strategies (REMS), explaining that the current process is unprecedented, unclear and potentially raises anti-trust issues that could leave companies open to litigation. Background In 2007, Prometheus Laboratories purchased Lotronex (alosetron hydrochloride), a t...