14
Jul
PostMarketing Study Requirements - Lachman Consultants

What Constitutes “Good Cause” for Noncompliance with PostMarketing Study Requirements?

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 […]

Read More
06
Jul
MaPP 5014.1 - Understanding CDER’s Risk‑Based Site Selection Model - Lachman Consultants

MaPP for Site Surveillance Inspection Procedure Gets a Facelift

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 […]

Read More
30
May

PMI – Add That to Your List of Acronyms as FDA Publishes a New Proposed Rule

Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients.  The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]

Read More
17
Apr

Biosimilar Interchangeability: The Need to Reconsider?

Introduction On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development.  The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In […]

Read More
13
Apr
Clinical Study Monitoring - Lachman Consultants

Q&A Document On Clinical Study Monitoring Offers Additional Information

The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions.  If you have been following the debarment notifications […]

Read More
05
Apr

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020.  As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

Read More
22
Mar
FDA Biosimilar Educational Resources - Lachman Consultants

New Biosimilar Educational Resources for Patients and Caregivers Released by FDA

Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars.  With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they […]

Read More
06
Feb

FDA Sees Better Adherence to Postmarketing Annual Reporting Requirements and Commitments

“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (PMC) is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation.” In previous years, the FDA […]

Read More
1 3 4 5 12