FDA Calls Out Manufacturer for Maintenance, Quality Control
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Source: Drug GMP Report
Cerno Pharma Hit With Warning Letter Over Adulterated Products
The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility. Source: Drug GMP Report
MHRA Cites Data Management, Integrity Issues in GCP Inspections
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Source: Drug…
‘Proactive Pharmacovigilance’ Essential to Combating Opioid Epidemic, FDA Says
Spotting shifting trends in opioid addiction and using a systematic approach to monitoring them is essential to protecting the public from the opioid crisis and intervening against it, top FDA…
Australian Manufacturer Nailed for Process Validation and Testing Shortcomings
The FDA hit Australian OTC drugmaker Jalco Cosmetics with a warning letter in a follow-up to a December inspection that revealed process validation and testing deficiencies at its facility in…
FDA Issues Revised Guidance on Developing Drugs for Complicated UTIs
The resolution of all original symptoms should be the primary efficacy endpoint in trials for complicated urinary tract infection drugs, according to a new FDA guidance. Source: Drug Industry Daily
CHMP Recommends Nine Medicines for Approval, Including Two Orphan Drugs
Stepping up its pace from just three recommendations in April, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval at its May meeting —…
FDA Weighs Opening Up Adult Cancer Trials to Adolescents
Adolescents should be allowed to join adult oncology clinical trials as long as the cancer or the drug target is the same in both adults and adolescent patients, the FDA…
Gottlieb Calls for Expansion of FDA Authorities to Fight IV Drug Shortages
FDA Commissioner Scott Gottlieb said the agency may ask Congress for more authority to deal with intravenous drug shortages but he also called for voluntarily collaboration by the industry. Source:…
Former Insys Sales Rep Pleads Guilty to Paying Kickbacks to Doctors
In the latest development over alleged misconduct by Insys in promoting its fentanyl-based opioid Subsys, a former sales representative admitted to participating in a scheme to bribe doctors to prescribe…
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