Pharma

Your Article Summary

See Latest Articles

Merck warned by FDA over vaccine plant failings
Corporate News Releases - The Healthcare Sales & Marketing Network, 05/08/08

The agency said Merck had filed an 'inadequate response" to a Form 483 sent to the company several weeks ago, and it now needed to see immediate corrective action. The agency highlighted several areas in which the plant deviated from good manufacturing practices (GMP). For example, Merck is accused of not investigating why some batches of product were outside of specifications, as well as "failure to maintain production and process control," according to the FDA.

Today in Drug/Product Approvals...keeping you current

Receive free subspecialty "5-minute updates" via email

Abbott Seeks FDA Approval of New Dosage Strengths of SIMCOR
Abbott, 12/11/09

Recombinant Human Erythropoietin, Epogin Injection Application for Approval of Additional Indication of Chemotherapy-Induced Anemia
Chugai Pharmaceutical Co., 12/08/09

Synthon announces European approvals for Raloxifene
Synthon, 12/08/09

 See all of Drug/Product Approvals

Today in Regulatory Issues...keeping you current

Receive free subspecialty "5-minute updates" via email

Sixteen Fired for Records Snooping
HealthDataManagement, 12/09/09

Watson Files FDA Application for Generic Rozerem
Watson Pharmaceuticals, 12/07/09

Bristol-Myers Squibb And Pfizer Announce Plans To Submit Regulatory Filing For Apixaban In Europe
Bristol Myers-Squibb Company, 12/07/09

 See all of Regulatory Issues