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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

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