Warning Letter Roundup: FDA Warns Five Firms Over CGMPs
The FDA issued warnings to five drug manufacturing facilities for numerous CGMP deficiencies and other issues. Source: Drug GMP Report
EMA Invites Comments on Water Quality Guideline for Drugmakers
The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use. Source: Drug GMP Report
FDA Moves to Modernize Inspections for Sterile Injectables
The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions. Source: Drug GMP Report
Advanced NHP Research Capabilities: Molecular Imaging
BTS Research has partnered with BioLaurus Inc. , an advanced molecular imaging group to bring new research capabilities to our pharma research clients. The gold standard for pre-clinical research has…
GAO Urges FDA to Improve Orphan Drug Reviews
The FDA granted orphan status to 26 drugs whose applications didn’t include all required information, , according to a Government Accountability Office report released on Friday. Source: Drug Industry Daily
Massachusetts U.S. Attorney Warns Opioid Prescribers Whose Patients Died
As part of its efforts to contain the opioid epidemic, the U.S. Attorney for the District of Massachusetts issued warnings to opioid prescribers whose patients died of overdoses. Source: Drug…
Sen. Merkley Proposes Bill Linking Drug Prices With Healthcare Access
Sen. Jeff Merkley (D-Ore.) introduced the Low Prices Drug Act (S.3680) — a bill that would tie drug prices to drugmakers’ access to Medicare and Medicaid patients and align U.S.…
FDA, WHO Unveil Pilot Program for Faster HIV Drug Reviews
The FDA announced plans Friday to collaborate with the World Health Organization (WHO) under a pilot program aimed at speeding up reviews of HIV drug applications. Source: Drug Industry Daily
WHO Considers Ways to Boost Access, Cut Prices for Cancer Drugs
In a wide-ranging analysis of ways to improve access to cancer drugs, the World Health Organization found the drugs remain costly even in countries with strict drug pricing regulations, price…
U.S.-EU Partnership on GMP Inspections Adds Five Countries
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement…
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