Drugs
The US FDA issued a warning letter to the Tianjin-based company on December 14, citing multiple significant deviations from Good Manufacturing Practice (GMP) regulations. The warning letter highlighted inadequate validation of analytical methods for detecting residual solvents, poor equipment design and maintenance, and a lack of process validation. The agency
Drugs
The Oread Biosafety Center, a pharmaceutical firm in Farmington, CT, faced issues during an FDA inspection in February 1999. Investigator Anthony Warchut of the New England District Office found several problems related to Standard Operating Procedures (SOPs) for non-clinical lab operations. The firm's lab operation was acquired from
Drugs
Escalon Medical Corp., a company specializing in ophthalmic products, has announced that its high-end digital camera system for ophthalmologists, known as the CFA Digital Imaging System, has received FDA approval. This system will be marketed through Escalon Medical Imaging, LLC, a joint venture with MegaVision, Inc. The digital cameras produced
Pharmaceutical industry
New Year's Eve festivities often come with a price: disrupted sleep patterns and health concerns. As millions of people gather to celebrate the start of a new year, many will find themselves sacrificing sleep for fun and festivities. However, poor sleep can have serious consequences for overall health,
Pharmaceutical industry
The U.S. Food and Drug Administration has accepted for filing the New Drug Application for d-methylphenidate, Celgene's chirally pure version of Ritalin. This marks a crucial milestone in the development and potential marketing of the drug, which is expected to be completed in the third quarter of
Drugs
The Food and Drug Administration has approved Botox, a botulinum toxin type A, as a treatment for cervical dystonia, a neurological movement disorder that causes neck spasms and pain. This approval is the second this month, following the approval of a similar drug, Myobloc or botulinum toxin type B, for
Pharmaceutical industry
As a former FDA inspector warns, pharmaceutical and biotechnology companies must be vigilant in ensuring the compliance of their lab computer software, as any lapses can result in severe consequences, including product recalls and complaints. A lack of understanding of validation and documentation protocols can leave firms vulnerable to FDA
Drugs
Glaxo Wellcome, the UK's largest drugs company, has abandoned plans to sell Lotronex, its irritable bowel syndrome (IBS) treatment, after US regulators demanded a recall due to safety concerns. The decision follows a failed attempt to persuade the US Food and Drug Administration (FDA) that Lotronex's
Drugs
The Food and Drug Administration (FDA) has asked the manufacturer of Lotronex, a treatment for irritable bowel syndrome, to remove the drug from pharmacy shelves after dozens of patients suffered serious side effects and at least three died. The FDA cited severe constipation and ischemic colitis, a lack of blood
Pharmaceutical industry
The US Food and Drug Administration (FDA) has issued warnings to several firms across the country for manufacturing and labeling violations. In October, the FDA warned a Florida firm, Sea Lobster Co. Inc., for serious deviations from federal HACCP regulations, causing their cooked stone crab claws and scombroid species to
Drugs
A recent study published in the December 21, 2000, issue of The New England Journal of Medicine has raised alarming concerns about the safety of popular dietary supplements containing Ephedra. Researchers at the University of California, San Francisco (UCSF) have concluded that these products can pose severe health risks, including
Drugs
Novartis Consumer Health U.S. has announced the voluntary withdrawal of its phenylpropanolamine (PPA)-containing cold and allergy products from retail store shelves. This decision comes after the U.S. Food and Drug Administration (FDA) requested that companies "voluntarily discontinue marketing any drug products containing phenylpropanolamine" due to
