iwewlkws FDA does not have a process for formal review of labels or advertisement material for approved medical device intended for patients and lay caregivers. Most Class I and several Class II devices do not require a doctor’s supervision to buy or use a given medical device. Historically, it was acceptable as most medical devices are used under supervision … Read more
The death toll from prescription opioids abuse has been soaring around the world over the past 20 years. It now exceeds fatalities from road accidents or deaths from heroin and cocaine in the United States, the United Kingdom and Australia according to a recent article in Nature magazine. As discussed in the article, some of the more promising … Read more
The FDA has finalized a new guidance recommending continuous refinement of analytical procedures and methods validation over the lifecycle of drug products based on new information collected over time. These recommendations will be additional to drug product quality documentation requirements that are standard during application for market approval or when there is change in the manufacturing process. … Read more
A recent report by two patent law professors, one from the US and one Denmark, raised concerns that reporting of detailed clinical trial information, as required under the current laws, could adversely affect the patentability of new uses of drugs. Analysis of full clinical trials data may reveal novel indications not previously known or obvious, making it … Read more
We consume a lot of drugs and they all end up polluting the environment. Human waste, urine and feces, are the primary sources of drugs found in wastewater and sewage from where it ends up into water bodies such as streams, rivers, lakes, seawater, and eventually, drinking water. FDA has several rules requiring companies to … Read more
FDA is planning to publish a guidance document on “clinical decision support” (CDS) software, i.e., software that interfaces patient data and clinical decision making, by the end of this year. There is intense speculation about what FDA’s approach to regulate CDS software may be. In this month’s edition of Nature Biotechnology, Elenko et al. examined the emerging regulatory framework … Read more
Last month FDA officials met Google experts and the web was buzzing with speculation about the context of the discussion. Both FDA and Google have kept mum about the topic of discussion but one of the Google attendees is an expert in data mining and has published articles on using web searches by people to link side-effects to drugs. … Read more
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
