On Tuesday March 24, 2020, Prime Minister Narenda Modi of India ordered an extensive lockdown of all of its 1.3 billion residents. “There will be a total ban of coming out of your homes,’’ Mr. Modi said. “Every district, every lane, every village will be under lockdown,’’ he said. “If you can’t handle these 21 […]
Remember the days when the biggest concern that both consumers and the pharmaceutical industry had was about potential contamination of medications by nitrosamines? Just a few weeks ago, rumors were flying around fast and furiously among patient groups on social media, firms were issuing recalls of numerous medications, and regulators were involved in issuing policies […]
Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]
The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]
In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID […]
Contract Pharma recently published an article addressing some valuable tips to make your trip along the regulatory pathway to report manufacturing changes easier. The author, Amy Schutte, Senior Associate, Regulatory Practice of Lachman Consultants says, “Change is inevitable, continuous, and reportable to the FDA when we are talking about approved human or animal drugs.” Specifically, […]
In response to the COVID-19 pandemic, FDA released guidance on March 14, 2020 allowing state licensed pharmacies, compounders, and certain federal facilities (referred to collectively as compounders) to manufacture hand sanitizers. In this guidance, FDA indicated that they are aware of people making their own sanitizers due to the shortage of sanitizers on the market, […]
Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers. We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well. Most of us think […]
FDA Commissioner Stephen M. Hann’s piece on the FDA website (here) provided, I believe, a very realistic view of what one might call a runaway CBD industry (if you read between the lines). “The Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
