Meningitis Deaths Prompt FDA Crackdown on Drug Mixing
Exclusive FDA News and Compliance Tips April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission Six months after a U.S. meningitis outbreak that killed 51 people put the spotlight on their industry, specialty pharmacies that mix their own drugs are falling short of federal safety and sanitation requirements. […]
Read More »Category : News
Bombshell – Judge Rules Morning After Pill Should Be Available to All
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission In what some are calling a landmark decision, a federal court judge has ruled that the morning after pill should be made available “without a prescription and without point-of-sale or age restrictions within thirty days.” The ruling follows more than a decade of […]
Read More »Category : News
Clawing Back Money from Bad Behaving Pharma Execs
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission After years of huge payouts to settle allegations of fraud, shareholder lawsuits and ensuing negative publicity, a half dozen drugmakers have agreed to revise their compensation policies in order to make it easier to recover payouts to executives in hopes of deterring unethical or inappropriate […]
Read More »Category : News
Pfizer Must Pay $142 Million for Neurontin Marketing
In a setback to Pfizer, a federal appeals court upheld a ruling that the drugmaker must pay $142 million after all to Kaiser Foundation Health plan for marketing the epilepsy drug for unapproved uses. The court also decided that lawsuits filed by other insurers and employers, which had been tossed by a lower court, can be revived. […]
Read More »Category : News
FBI Investigates Omaha Pharmaceutical Company
Channel 6 in Omaha, NE is working to find out what the FBI was doing at an Omaha pharmaceutical company Wednesday afternoon. Workers nearby said they saw FBI agents at Pharmaceutical Technologies, Inc. near 136th and California. The Omaha bureau said local agents are assisting another agency with the investigation. They referred us to the […]
Read More »Category : News
No FDA Guidance on Social Media Leading to Higher Enforcement?
Mark Senak, author of EyeOnFDA blog, assembled a database of FDA/OPDP Warning and NOV letters spanning the years 2004-present and wrote an informative white paper review of the data (find it here). April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission “Lacking any sort of formal guidance from […]
Read More »Category : News
Bugs and More Bugs – An FDA cGMP Inspection Disaster
April 3, 2013 We came across a recent warning letter issued by FDA to an API supplier in Japan called Asada Milling. We would like you to take note if you have any drug products in your home that contains anything handled by this firm. Why, you ask? Because the list of FDA cGMP violations […]
Read More »Category : Compliance Tips &News
FDA Criticized For TB Drug Approval
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission Late last year, the FDA approved a first-in-class medication to treat multi-drug resistant tuberculosis. The agency did so after an advisory committee unanimously recommended accelerated approval for the drug, which is called Sirturo and marketed by Johnson & Johnson. […]
Read More »Category : News
Hundreds of Bugs Crawling in API Processing Areas? – cGMP Inspection Disaster
A recent warning letter issued by the FDA to Asada Milling, an active pharmaceutical ingredient supplier based in Japan, may prompt you to ask whether a drug in which you have any type of  interest contains their products. Why? The list of violations is long, serious and disturbing. Consider the following deviations from good manufacturing […]
Read More »Category : News
Harsh FDA Social Media Enforcement – Not Really, Report Finds
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 3, 2013 A new report by the Eye on FDA blog has published an interesting report that attempts to assess the regulatory actions of FDA’s Office of Prescription Drug Promotion that were due to the increased usage of digital and social […]
Read More »Category : Compliance Tips &News
