In February, FDA pushed hard against a cancer drug arguing that data from the China-only clinical trials was not acceptable for US approval. But does it imply an FDA policy or a one-time decision? Another cancer drug, this time for a rare cancer common in Asian population, with a similar China-only clinical trial may answer … Read more
In July 2016, FDA approved Sarepta’s DMD drug, and in June 2021, it approved Biogen’s Aduhelm for Alzheimer’s disease, both times going against the vote of its Advisory Committees. Now FDA is being lobbied again by patient groups to approve Amylyx’s AMX0035 for ALS despite a no-vote from the Advisory Committee. Is FDA ready for … Read more
A company that manufactures thermometers that predicts fertility status of women sued a vigorous critic of their product for defamation, and the courts dismissed the lawsuit citing protection of the expression of opinion affirming well-established dogma that people can opine freely about a product, negatively. Valley Electronics, the makers of Daysy, the thermometer that calculates … Read more
Recent changes to medical device rules in the EU have made it harder to get CE mark and effectively pushed companies to seek FDA approval prior to the CE mark, found a recent survey of predominantly US-based companies. FDA is perceived to be more responsive and predictable compared to its European counterparts. Traditionally, US-based medical … Read more
Although many of the pandemic related restrictions are easing across the country and many part of the World, it does not seem that the government will be ready to formally declare that the pandemic emergency is over and many of the practices implemented during the emergency would likely stay for good. While the start of … Read more
All manufacturers of FDA regulated products are required to be “recall ready” per specific criteria set by the FDA, at all times, failure to do so could lead to FDA compliance actions. The primary target audience for the new FDA guidance on the topic appears to be manufacturers of food, supplements, cosmetics, and many other … Read more
In a public service announcement this week, FDA stated that there is no evidence that cell phone use causes cancer in children and teens. This was based on a recent study in about 2800 children and teens in 14 countries: 900 kids with brain tumor and 1900 healthy kids. Cell phones emit radio frequency (RF) … Read more
Clinical trials in the US lack demographic diversity. Multiple programs from FDA in the last 5-10 years to boost higher clinical trial participation from Black and Latino patients in the US have failed. However, recruiting patients from countries in Africa and South America has not been discussed much even though it may be one way … Read more
The US government shipped free home tests for Covid to every home in the US. The magnitude of this event should not be lost. It is the first time that home tests for any infectious disease got such a strong endorsement from the Federal government. Does this indicate that home tests for other infectious diseases … Read more
Even though the US government has not officially withdrawn the Declaration of Public Health Emergency (PHE) related to Covid from February 2020, there are multiple reports that FDA is not accepting any new Emergency Use Authorization (EUA) applications for diagnostic products under that Emergency. Typically, such rejections from the FDA come with a suggestion to … Read more
