Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously. There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]
Join Lachman Consultants at GRx+Biosims™ 2023 in North Bethesda, MD, Oct 2 – 4 for three days of insights and engaging discussions around the most pressing issues vital to the generics and biosimilars industry. Lachman will be represented by several members of the team, including: Frances Zipp, President & CEO Bob Pollock, M.S., Outside Director […]
The new Form FDA-356h was released in July 2023. The FDA’s expectation is that the newly revised form (which has an expiration date of March 31, 2026) should be utilized when submitting new drug applications, abbreviated new drug applications, and biologics license applications for human use. The new form can be downloaded from a link that […]
Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here). Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections. The proposed Guidance […]
Yesterday, the Committee on Oversight and Accountability of the House of Representatives issued a press release (here) after the hearing on Pharmacy Benefits Managers (PBMs) and their impact on drug pricing. The press release is titled “Hearing Wrap Up: Pharmacy Benefit Managers Push Anticompetitive Drug Pricing Tactics to Line Their Own Pockets.” I guess this […]
Once again, AAM reports the data from the IQVIA 2023 U.S. Generic and Biosimilar Medicines Savings Report (here) which demonstrates the savings power from generic drugs and biosimilars. The Report indicates that, in 2022, the savings realized from the use of generic and biosimilars hit a record $408 billion, of which $9.4 billion was from […]
The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information […]
When it comes to investigating OOS results, a clear line should be drawn between the responsibilities of a contract testing laboratory (CTL) and that of the manufacturer/sponsor. Before we come to the testing part, here are some questions (not all inclusive) to be asked by your firm before selecting a CTL for outsourced testing: (1) […]
On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]
The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024. BsUFA Fees The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]
