• Regulatory NewsRegulatory News

    Antifreeze and APIs don't mix, FDA tells Syntec

    The US Food and Drug Administration has warned New York-based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ingredients (API) compromise the safety of the drugs produced at the site.   Among the problems found by FDA at the firm’s site in Farmingdale, NY, were inadequate contamination safeguards, as well as lax cleaning and testing proced...
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    PIC/S finalizes GMP data integrity guidance

    This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.   When authorities inspect facilities of manufacturers and distributors of active pharmaceutical ingredients to ensure good manufacturing practice and good distribution practice (GMP/GDP) compliance, “The effectiveness of these inspection processes...
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    Biden administration outlines plan to address US supply chain vulnerabilities

    The United States is taking steps to address vulnerabilities in US supply chains, according to a new report published by the White House.   These steps include improving domestic manufacturing of critical medicines and active pharmaceutical ingredients, increasing investments in sustainable domestic supply chains, and better monitoring of supply chain disruptions, the Biden administration said.   On Monday, the Biden administration released a report of findings f...
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    FDA officials address 'complete assessments' at DMF workshop

    The US Food and Drug Administration (FDA) held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially derail the agency’s on-time review of generic drug applications.   The 3-hour webinar covered such topics as fee payments, completeness assessments, impurity assessments, facility identification and selecting starting mater...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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    Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority

    A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently. The FDA  warning letter , dated 26 July for Tianjan, China-based Concept Products Limit...
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    House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

    Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...
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    Compounders Beware: API from China May Be Contaminated, FDA Says

    The US Food and Drug Administration (FDA) late Wednesday released a warning for drug compounders that certain lots of the active pharmaceutical ingredient (API) baclofen, manufactured by China’s Taizhou Xinyou Pharmaceutical & Chemical Co., may be at risk for contamination. “FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in inje...
  • FDA Plans Major Overhaul of Recall Reporting

    The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...