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Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
The NIH Clinical Center suspended operations of its Pharmaceutical Development Section, effective Thursday, due to serious manufacturing problems and lack of compliance with standard operating procedures discovered during an FDA investigation. Read More
Active pharmaceutical ingredient maker VUAB Pharma was hit with an FDA warning letter over complaint handling, contamination and data integrity issues. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
The FDA has warned three more drug compounding pharmacies over sterility issues and other GMP shortcomings, bringing to 12 the number cited since October. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said Monday, adding that the current system of different expectations is not sustainable. Read More
HHS’ Office of Inspector General has added four new projects to its 2015 work plan, including the creation of a Medicare Part D oversight portfolio and a review of states’ reporting on Medicaid rebate collections. Read More
The FDA has hit Actavis with a warning letter for making unsubstantiated claims about its Rapaflo benign prostatic hyperplasia drug on a company webpage. Read More
Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. Read More
The project is expected to benefit more than 4,000 companies by relieving them of the job of monitoring the medical literature for these substances. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More