This week Amylyx’s ALS drug was approved by the Canadian regulators raising speculations that this would make it very hard for FDA to reject this drug despite the negative vote by the FDA’s Advisory Committee which based its recommendation on the underwhelming clinical trial data from the one pivotal trial conducted by the company. But … Read more
In the last two and half years, FDA has approved hundreds of EUAs for various products for the diagnosis, management, and treatment of Covid-19. However, EUAs are temporary permits to sell products which ends when the emergency is declared to be over, i.e., the emergency declaration is withdrawn. An appropriate market approval (510k, PMA, NDA … Read more
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
