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May 11, 2017
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
May 09, 2017
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 05, 2017
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 02, 2017
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.
May 01, 2017
The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.
April 27, 2017
FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.
April 21, 2017
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
April 06, 2017
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
April 05, 2017
Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.