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Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here).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 […]
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) […]
This morning, the FDA published a revision to the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies guidance originally issued in draft in 2019 and then finalized in 2020. The revision provides for another one-year delay in enforcement for the […]
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 […]
With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]
The FDA answers this question in a newly released guidance titled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (here). “[H]olders of applications for human prescription drugs (hereafter applicants) who are required to conduct postmarketing studies or clinical trials under section 505(o)(3) of the […]
The ISPE 2023 Biotechnology Conference was held from 26 to 27 June in Dublin, Ireland. Much of the focus of the conference was Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMPs), terms used in the US and EU for a range of emerging therapies and products in various stages of development. At the […]
The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]
