iwewlkws When manufacturers of pharmaceutical products rise above the minimum GMP standards, they should be rewarded with fewer FDA audits, higher prices for their products, and strong support from clinical stakeholders, according to a White Paper from FDA this week. FDA believes that such manufacturers will also reduce the likelihood of supply disruptions and shortages. The … Read more
Traditionally, a medicine is something intended to treat a specific disease while food is consumed for nutrition. But with increasing evidence linking the food we consume to our diseases and health, can doctors prescribe food to prevent, treat and/or manage diseases just like they would prescribe a drug for similar purposes? What would be the … Read more
FDA has maintained enforcement discretion for CBD products by only warning companies that make overt medical claims about their CBD products but not doing much to stop the overall sale of these products. This week in a Warning Letter to another company selling CBD gummies, FDA explicitly stated that CBD products are drugs and not … Read more
Last week Fox News commentator Tucker Carlson aired a “promo for a show” that promoted a medical device for male sexual enhancement based on exposing the testicles to red light. Although the “news” was quickly debunked and subjected to memes, it is not hard to imagine fans of Tucker Carlson to still consider the information … Read more
An FDA annual report on compliance inspections released this week confirms that the practices of remote inspections and use of alternate ways to monitor compliance by FDA inspectors, that became necessary during the peak of the pandemic, stayed prominent even as the pandemic waned. Remote inspections are frowned upon by the government watch dogs such … Read more
As of this week, there are still 119 Covid vaccines being tested in clinical trials with about 50 in late-stage clinical trials and more than 75 in preclinical testing. It would be mind-boggling for anyone to understand the rationale for developing these new vaccines and even harder to imagine the hardship the developers must face … Read more
This week FDA issued “marketing granted orders” (Order) for tobacco flavored e-cigarettes tacitly accepting that these devices can effectively help smokers quit conventional cigarettes and that they pose minimal risk of initiating new smokers. Despite the disclaimers in the announcement that “this does not mean these products are safe nor are they “FDA approved”, most … Read more
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
