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More than a year and half after the approval of the first two Covid vaccines, Novavax seems to be finally getting ready to secure its own EUA for its Covid vaccine, but is it too late to the market? The vaccines from Pfizer and Moderna have taken up a seemingly unsurmountable position in the market, … Read more

It took about 11 months from the beginning of the world-wide spread of Covid-19, in Jan 2020, to getting available an exceptionally effective vaccine to it. But this breakneck speed of development is an exception and should not be expected to be repeated for all other diseases and infections. The conventional wisdom of needing about … Read more

A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both. … Read more

The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be widely used to … Read more

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

The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be widely used to … Read more

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