Today, the FDA issued a total of thirty Product Specific Guidances (PSGs) – twenty‑one new and nine revised (here). The FDA notes that all twenty‑one newly issued PSGs are for drug products for which there are no approved ANDAs. In addition, of the thirty guidances issued, nineteen are for complex products (fourteen new and five […]
Lachman Consultants’ Vice President Ricki Chase joined Arnold & Porter to discuss the introduction of the Modernization of Cosmetics Regulation Act (MoCRA) including FDA’s authority to formalize good manufacturing practice (cGMP) requirements for the cosmetics industry. This is a landmark change to how cosmetics are filed, manufactured, traced, and reviewed by the Food and Drug […]
Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? This could be a difficult self-reflection for weak supply chains, devastated by the pandemic. The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply […]
On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]
Just think about the number of EUAs granted for at-home COVID testing. Then think of the information that is not being captured because people aren’t reporting the outcomes of all those home-administered tests. Remember the days when the number of reports of positive cases were daily headlines? Now, no one knows—or maybe it’s that so many […]
Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023. Access!™ is where policymakers, influential speakers and industry leaders […]
This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business! The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda. The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults. The […]
With just about half of the month gone, and given that there have already been two holidays in January, the reported number of full-approval and tentative-approval actions looks pretty promising. Through January 17th at 9 a.m. Eastern time, the OGD has listed twenty-eight full-approval actions and ten tentative-approval actions in the All Approvals database for a total […]
The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children. In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections. The problem with the drug was that it was very bitter, and, because of this, children […]
Obviously, we have waited longer for the official monthly statistics in FY 2023 than in previous years. In addition, in prior years, OGD published the approval actions, receipt of new ANDAs and complete response letters prior to releasing the full set of statistics. However, it looks like there will be no early view of these […]
