On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages. In this Q&A, FDA provided the following guidance: Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]
Remote work by the generic drug program staff did not seem to negatively impact the approval actions for ANDAs in March. The entire generic drug program staff was likely feeling the same (or even higher) anxiety that we are all feeling, with the stay at home orders in place. Speaking from experience, the coordination for […]
These days, everybody’s attention is focused is focused on COVID-19. However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared. In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!). Yesterday, the […]
March 2020 has got to go down in the history books as one of the most disruptive months of the last forty-four years (that is how long I have been in the pharmaceutical arena). COVID-19 is running rampant across the country. Many states are in lockdown and social distancing seems to be the new norm. […]
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 […]
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, […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
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 […]
Well, here we are in 2020, almost halfway through GDUFA II, and what do we know? We know that the OGD expects approvals to slow down, but original ANDAs to begin to fill up the system again. We have already seen the slowdown in approvals and, according to the OGD, this is likely to continue […]
