CDER Shifts Dispute Resolution Program Due to Spike in Appeals
An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New…
FDA Clarifies ‘Outsourcing Facility,’ Requirements for 503A Compounders
The FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Source: International Pharmaceutical Regulatory…
TGA Overhauls Advisory Committee Conflicts of Interest Guidance
Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Source: International…
Time Between FDA Inspections and Classification Letters Shrinking
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, according to one of the agency’s top…
MHRA Cites Data Management and Integrity in GCP Inspections
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Source: International…
EMA Conducts Fewer GMP, More GCP and Pharmacovigilance Inspections
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the…
FDA Pulls Plan for Risk-Based Biologics Inspections
The FDA withdrew a direct final rule to amend biologics inspection regulations and said it will rewrite it. Source: International Pharmaceutical Regulatory Monitor
FDA Issues ‘Streamlined’ Trial Guidance for Hematologic Drugs
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying…
EMA Issues Q&A on Health-Based Exposure Limits
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: International Pharmaceutical Regulatory…
FDA: Inspection Agreements With EU Done by Next Summer
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s senior international officials said. Source: International Pharmaceutical…
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