FDA published a conversation piece on narrow therapeutic index drugs entitled, “Setting and Implementing Standards for Narrow Therapeutic Index Drugs” (here ) to better inform health care professionals (HCP), patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index (NTI) drugs. Let’s look at what an NTI drug is […]
Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]
First, please be aware that many of the numbers you may have seen reported in our blog posts for various OGD actions were reported for Fiscal Year 2023, which ran from October 1, 2022 through September 30, 2023. The Office of Generic Drugs 2023 Annual Report (here) is a bit different as it reports OGD actions from […]
Based on approvals posted through February 16, 2024, the OGD has issued 28 full-approval actions and 5 tentative-approval actions so far in the month of February. Given that February is a short month to start with and has one federal holiday, we may get additional help as it’s a leap year and the additional day may […]
Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration fee. When this draft is finalized, it will supplement the Medical Device User Fee Small Business Qualification and Certification Guidance and address the waiver provisions of the […]
In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]
ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]
Today, the OGD published a list of 29 new Product-Specific Guidances (PSGs) and 33 revisions to existing PSGs, all of which have been added since February 15, 2024. The listing can be found here. This publication is different than the one we wrote about in another blog today regarding the FDA’s plans for issuance of new […]
Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions. Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received. The OGD officially issued 53 approval actions in […]
At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals. The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals. Here are some of the points […]
