Since 2011, FDA has required many sponsors of newly approved drugs to conduct mandatory post-marketing safety studies. These studies could be required as a post-marketing commitment before a drug can be approved or if a new safety concern is raised after the product becomes available in the US market. FDA also advises the manufacturers about the … Read more
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the … Read more
In a report released by European Medicines Agency (EMA) earlier this month, auditors from the Agency found many clinical sites to have several major deficiencies in compliance with Good Clinical Practices (GCP). About 58% of the findings related to errors in study documents, either poor source documents or bad documentation practices, while about 15% findings were related … Read more
The public opinion in the US is getting increasingly negative for the high prices of prescription drugs. A course of treatment for some hepatitis drugs could cost $95,000; multiple cancer drugs cost about $150,000 per course, while a couple of drugs for the rare disease cystic fibrosis could cost more than $300,000 for a single course of … Read more
Every year regulatory agencies from all over the world jointly conduct an international week of action, called Operation Pangea, to go after online pharmacies selling counterfeit and illicit medicines and post their results publicly to create awareness about the dangers of buying medicines from internet pharmacies. This operation is coordinated by INTERPOL which brings together customs, … Read more
Starting 1st of September this year (2015), FDA will require all manufacturers of drugs or biological products including manufacturers of blood or blood components for transfusion to notify FDA electronically of a permanent or temporary discontinuation in the manufacturing of their product that is likely to lead to a significant disruption in supply of that product in the … Read more
Despite a well-known and scientifically accepted practice of using blinded studies to support a claim, it is still not uncommon for well-intentioned researchers to conduct open-label studies leading to highly biased results. In an article published in the PLOS journal by three Australian researchers, a review of 960 peer-reviewed articles in 5 different animal behavior journals found that … Read more
Some Warning Letters demonstrate that quality of training of FDA Inspectors. FDA Inspectors are trained to pay close attention to seemingly minor observations to catch errant manufacturers. Recently, in a Warning Letter issued to a manufacturer of oxygen tanks, Trans Ox located at West Columbia, South Carolina, FDA inspectors identified several discrepancies in documents and gross violations … Read more
Since the launch of the Breakthrough (BT) designation program by FDA in July 2012, there have been more than 200 requests for this designation just to CDER, along with several additional to CBER. FDA granted about one-third of the requests, and rejected the other applications for either lack of clinical evidence, safety issues, or no significant improvement … Read more
Whenever a new drug is disapproved, FDA issues a complete response letter (CRL) to the manufacturers citing all the reasons why it was rejected. These letters contain details of the applicant’s development program with specific deficiencies identified and potential solutions offered. The CRL becomes the roadmap for the applicant to satisfy FDA’s concerns and eventual … Read more
