An email from the FDA explained that on March 17, 2023 the FDA added information to the Purple Book Database of Licensed Biological Products (here) to include information on new reporting requirements established by the Section 3201 of the Consolidated Appropriations Act of 2023. According to the Purple Book Q&A #8: “Section 506I(c) of the […]
Let me start off by saying Holy Cow! This month looks like it could be a blockbuster for approval actions, but there are some interesting factoids that must be taken into account. Let’s look at the reported approval actions posted through March 15th and I will further explain some of the twists. It looks like […]
The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.” The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]
When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]
We have seen several changes from FDA with the roll-out of GDUFA III. Some have been a little frustrating (Controlled Correspondence blog coming soon!), but some have been pretty great! On February 17, 2023 FDA issued a new GFI, “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA” (here). This GFI seems to point […]
The release of CDER’s OPQ 2022 Annual Report is a grand opportunity for an “Agency and industry” calibration to ensure alignment of performance and strategy. In any journey, it is prudent to check your compass, map, and progress to date to ensure your trip stays on course. The report efficiently states the strategic priorities, performance […]
Hello from sunny Orlando and the AAM annual meeting! The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address. She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total […]
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 […]
