This is the second edition of the “Did You Know?” series featuring some of the lesser known (or at least widely known) aspects of the GDUFA III program changes and the impact on the generic drug industry. Today we will focus on elements of Pre-ANDA Development Program. GDUFA III has opened the door for additional […]
Lachman Consultant Services, Inc. is proud to be a Gold Sponsor of the 2023 PDA Robotics and Automation Conference. Taking place on Wednesday, May 3rd and Thursday, May 4th, 2023, in Amsterdam, The Netherlands, the two-day gathering builds a roadmap to digitization designed for drug manufacturing. This annual conference is designed to catalyze the transition […]
The CDER Small Business and Industry Assistance (SBIA) presented a two-day seminar on April 12-13, 2023, celebrating the first 10 years of GDUFA. With the Office of Generic Drugs and industry now operating under the third iteration of GDUFA, the presentations by FDA Agency covered a lot of ground in an effort to highlight the […]
With half of April in the books, the number of OGD approval actions posted as of April 14th includes twenty‑seven full‑approval actions and four tentative‑approval actions for a total of thirty‑one approval actions. It looks like the OGD is heading towards an average approval month for April. Average definitely isn’t a bad thing, especially since […]
FDA 510(k) is a submission process that medical device manufacturers need to go through to receive clearance from the US Food and Drug Administration (FDA) in order to legally market their products in the US. The FDA 510(k) process is essential for ensuring public safety by confirming that medical devices meet the necessary standards and […]
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 […]
Those of us in the industry are usually reasonably technically savvy and can understand some of the more complex guidance documents that the FDA issues. However, there are times that even those among us in the industry, depending on our individual academic tracks and professional experiences, whether regulatory, CMC, bioanalytical, pharmacokinetics, medical, and on and […]
After 12 years on the market under an accelerated approval, the application holder for Makena has failed to provide sufficient efficacy data to the FDA to support continued marketing. The FDA said “[T]oday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena.” The 26 page final decision (here) can […]
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 […]
The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]
