Pharmaceutical industry
The U.S. Food and Drug Administration (FDA) has accepted for review Schering-Plough's New Drug Application (NDA) for posaconazole oral suspension, potentially providing a new treatment option for severely immunocompromised patients with invasive fungal infections. The review process is expected to conclude within 10 months from the date
Pharmaceutical industry
The US Food and Drug Administration (FDA) has issued responses to three Citizen Petitions filed by pharmaceutical manufacturers, denying petitions that sought to prohibit the marketing and distribution of reduced-price authorized generic versions of brand-name medicines. The FDA's decisions aim to promote competition, increase access to lower-priced prescription
Pharmaceutical industry
Pharmaceutical companies are increasingly facing prosecution for encouraging non-approved uses of drugs, with the Department of Justice (DOJ) focusing on marketing and sales practices that promote off-label use. Virginia Gibson, Associate U.S. Attorney for the Philadelphia area, stated that the DOJ is interested in companies that initiate and encourage
Pharmaceutical industry
Mylan Laboratories Inc.'s subsidiary, Mylan Bertek Pharmaceuticals Inc., has made significant progress in the development of nebivolol, a treatment for hypertension. The company has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which has accepted the submission for review. Clinical trials
Pharmaceutical industry
Genasense, an experimental cancer treatment, showed mixed results in a Phase 3 trial for advanced melanoma patients. While it improved progression-free survival and response rates, it failed to demonstrate increased overall survival. The Oncologic Drugs Advisory Committee (ODAC) of the FDA voted that the evidence did not provide substantial evidence
Pharmaceutical industry
At the US Food and Drug Law Institute conference, Jeffrey Reidler emphasized the importance of transparency in corporate disclosure, particularly in light of the Sarbanes-Oxley Act, which has led to new rules on internal controls and auditor independence. Despite concerns about the transparency of drug company disclosure, Reidler noted that
Pharmaceutical industry
The patent on Rebetol, a drug used to treat hepatitis C, expired in June, but a generic version of the medicine has yet to receive FDA approval due to a dispute over the drug's label. Three Rivers Pharmaceuticals, the company seeking to sell the generic version, filed an
Pharmaceutical industry
The U.S. Food and Drug Administration (FDA) has approved HUMIRA (adalimumab), a human monoclonal antibody, for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease
Drugs
Cell Therapeutics, Inc.'s novel cancer drug treatment, Trisenox, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of both chronic myeloid (CML) and acute myelocytic (AML) leukemias. This designation, combined with other recent recognitions, brings the total number of
Drugs
A warning letter was sent to JOAMCA Chemical Products on November 13, 2001, citing various violations related to quality control and manufacturing practices. The letter highlighted the firm's failure to validate cleaning procedures for drug-making equipment and maintain records of equipment cleaning. Additionally, JOAMCA was cited for lack
Pharmaceutical industry
In June 1999, a FDA audit at Abbott Labs Hospital Products Division in McPherson, KS, uncovered several critical issues, including problems with the validation of a pentose assay method, insufficient surface sampling, and non-compliance with environmental control requirements. Key Takeaways: * The FDA audit, conducted by CBER microbiologist Cynthia Whitmarsh and
Pharmaceutical industry
FDA officials and compliance consultants pointed out during the International Business Communications' (IBC) FDA Compliance Summit in Coronoado, CA, that development reports are being closely examined in post-approval Good Manufacturing Practice (GMP) inspections for both drugs and biologics. This trend was echoed by biotech executives, who reported that inspectors
