Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry. High […]
The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]
I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market. Firms need to […]
At first blush, it does not seem like we have that much to be thankful for in 2020, between the pandemic, polarized political views, a contentious election, worry about loved ones, quarantine and stay at home orders, restaurants closing and opening, only outside eating, and hospitals jammed packed and people dying, jobs disappearing and Federal […]
Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections. Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]
In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic. However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern. On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]
Another day, another early morning on the West coast. While I am an early riser, 5:30AM is even a chore for this old FDA-er! But here we go! The morning began at the AAM GRx-Biosims meeting with Dr. Sally Choe, Director of the Office of Generic Drugs, as she provided a current program summary. We […]
On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]
According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP audits and inspections using interactive video or other types of interactive tools and techniques. He noted that many companies have volunteered use of […]
How long has it taken for a Final Standard Memorandum of Understanding (MOU) for States regarding Compounding Pharmacies to be issued? Are States or appropriate agencies (referred to as States below) ready to sign, acquire infrastructure, hire the necessary human resources, develop the enabling documentation, execute the requirements of the provisions, create the necessary records, […]