A Government Accountability Office (GAO) investigation found that FDA officials did not report potential political interference to influence their decisions due to lack of a formal process for the same or for fear of retaliation. The GAO recommended that FDA, CDC, and NIH should develop formal procedures for training personnel in reporting allegations of political … Read more
This week FDA released a public warning about Lab Developed Tests (LDTs), specifically non-invasive prenatal screening (NIPS) tests, which puts the responsibility on the patients to verify the reliability of these tests while making statements that could be seen as pandering to the concerns of conservative politicians who objected to NIPS tests on religious grounds. … Read more
Companies developing generic versions of complex drugs are eligible for enhanced support from the Office of Generic Drugs (OGD), mainly via pre-submission meetings under Generic Drugs User Fee Act (GDUFA) with the OGD reviewers to discuss bioequivalence testing requirements. However, FDA’s process for defining a complex drug was not very clear, till now. This week … Read more
Despite more than 10 years of prodding the industry, most products approved by FDA are still based on clinical trials conducted mostly on Caucasian volunteers. In future, FDA will require that sponsors present a formal written plan to recruit underrepresented racial and ethnic populations in the US for pivotal trials with drugs, biologics, and medical … Read more
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
