FDA Inspectors Find Mess During Audit of TN Pharmacy
Latest FDA and cGMP Compliance News A pharmacy in Tennessee is thought to be the main source of another outbreak of fungal infections, and FDA found the pharmacy in disorder during an audit in May.It found, for example, spiders in the clean room and there were no written procedures to assure that the products were […]
Read More »Category : News
Japan Terminates Recommendations for HPV Vaccines
Latest FDA and cGMP Compliance News In a big blog to pharmaceutical companies that sell HPV vaccines, the health ministry in Japan has pulled its recommendation for getting vaccinations after there were hundreds of reports of side effects, including numbness and long term pain problems, among other issues. The vaccines are going to be available […]
Read More »Category : News
FDA Issues Medical Device Alert Over Malware
Latest FDA and cGMP Compliance News FDA today issued an alert stating that medical devices that have computer systems could could have cyber security breaches and be vulnerable to malware. FDA noted that medical devices are interconnected more and more, through the Internet, networks in hospitals, and to other devices and smart phones. So there […]
Read More »Category : News
FDA Zeroes in On Patient-Focused Drug Development
Latest FDA and cGMP Compliance News FDA has long gotten input from both patients and caregivers about treatment options. FDA also has long included the perspectives of patients at advisory committee meetings, and also when new drug and device products are reviewed at special meetings held by FDA. In recent years, FDA is encouraging and […]
Read More »Category : News
Major Operations Overhaul at Merck by New R&D Exec; Layoffs Coming
Latest FDA and cGMP Compliance News The new head of research and development at Merck, Roger Perlmutter, is making moves quickly to overhaul operations there, also known as Merck Research Laboratories. Some of the changes means that a number of top management roles were cut, such as franchise heads and site heads. The licensing unit […]
Read More »Category : News
New Warning Letter Shows FDA Moving Beyond Basic cGMP Issues
Latest FDA and cGMP Compliance News Industry experts have told us that a new FDA warning letter to a company for manufacturing supplement products that have only five percent of the declared nutrient levels, indicates that FDA is becoming more advanced in testing finished products. A May 22 warning letter to Metaugus Inc. in Cedartown […]
Read More »Category : News
Major Insurer Stops Coverage for Compounded Drugs
Latest FDA and cGMP Compliance News We now have some new fall out from the scandal involving compounding pharmacies. Harvard Pilgrim Health Care, one of the biggest insurance companies in New England, is not going to cover specialty compounded medications because of cost and safety concerns, according to the Boston Globe this week. You will […]
Read More »Category : News
Read Latest 483s and Warning Letters With FDA Digest!
We are pleased to announce our new e-newsletter, FDA Digest! This unique publication provides you with monthly updates on FDA news, compliance tips, and much more. One of the unique aspects of this newsletter is that each monthly issue has complete reports on recent FDA 483s and warning letters. You can learn what exactly FDA […]
Read More »Category : News
Why Are Most Americans Ducking Clinical Trials?
Latest FDA and cGMP Compliance News Even though there is always more demand for new and better medical treatments, pharmaceutical companies often say that getting people to enroll in clinical trials in the US is quite difficult. One of the most common reasons is that a large number of our population has good access to […]
Read More »Category : News
Pfizer and Teva Reach $2 Billion Deal on Patent Spat
Latest FDA and cGMP Compliance News After almost 10 years of fighting, Teva Pharmaceuticals and Sun Pharmaceuticals agreed to settle on a very hot patent fight with Pfizer on the acid reflux drug Protonix. The agreement was to pay Pfizer $2.15 billion. Teva specifically will pay $1.6 billion and Sun will pay out the remainder. […]
Read More »Category : News
