iwewlkws Only 16% of the times when a company gets a Refuse to File (RTF) notification, it tells the public about it, and even then, only 5% of the times, the company accurately discloses the reasons for the refusal, FDA reports. Companies obviously want to control the negative information about their applications and FDA want to … Read more
Last week after FDA persuaded its oncology drug advisory committee to soundly reject a new drug approval application due to it being based on clinical data exclusively from China, some may have been given the impression that FDA no longer accepts clinical data from China for market approval in the US. It is far from … Read more
The FDA would soon have a new commissioner and among several leading contenders for the position is the 37-year veteran of FDA, Dr. Janet Woodcock. Like others, we speculate if this is the year, she finally becomes the FDA commissioner. This has been a good year for experienced people who outperformed others in highly competitive … Read more
On 27 January, the European Parliament adopted a legislative measure that would require any company doing business in Europe to assure that its entire supply chain is devoid of human rights and environmental abuses. This law would likely impact the pharmaceutical supply chains hard as they depends heavily on vendors in countries with suspected non-compliance … Read more
Apparently, FDA has been getting calls from consumers asking about where to get the Covid vaccines leading it to release the public announcement that it does not control distribution of vaccines, only their approval. It is obvious to the regulated industry, but the public has a different perception of the FDA, in that FDA is … Read more
It is no secret that FDA stopped all GMP inspections in March of last year due to the pandemic and then resumed highly curtailed risk-based prioritized domestic audits in the Fall. All through FDA used alternate ways to verify GMP compliance for US and foreign manufacturers. But the GAO does not believe it is acceptable … Read more
A review of Tweets from the winter season of 2019-2020 originating in Europe show that there was a jump in tweets about cases of pneumonia and unexplained illness across several European countries. Now we know that those were the early COVID-19 cases. Another review of social media messages originating around the same time in China … Read more
With two vaccines being used to rapidly vaccinate most Americans, it seems the other vaccines under development are either moving to other countries or getting out of this program. Many countries have eased approval of 2nd and 3rd tier vaccines to vaccinate their populations purely for financial and logistical reasons. How the world vaccinates its … Read more
Last year FDA approved the same number of new drugs as the previous two years demonstrating that the pandemic related disruptions did not affect the timelines for the new drug approvals. Also, like previous years more than half of the approved new drugs were intended for rare or orphan diseases and almost three-fourths (74%) of … Read more
With a new administration comes a general perception that it will bring major changes at the FDA. But new administrations do not affect most of the operations of the FDA, at least not immediately, and certainly not for most of the regulated industry. The most visible changes are at the administrative levels with a new … Read more
