On October 17, 2016, FDA announced “that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international…
Following is an excerpt from the Executive Summary (Click here for the Final Rule; 81 FR 69580) “Title XI of the MMA addressed two key concerns identified in a Federal Trade Commission (FTC) report on anticompetitive strategies that may delay access to generic drugs by: (1) Limiting the availability of 30-month stays of approval on…
“To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.” On…
FDA has released a new draft guidance “intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time. The draft guidance is intended to address concerns that new FDA-approved…
October 3-5, 2016: Nobel Prizes in Physics, Chemistry and Physiology Announced • Physics 2016: David J. Thouless, F. Duncan M. Haldane and J. Michael Kosterlitz for “theoretical discoveries of topological phase transitions and topological phases of matter” • Chemistry: Jean-Pierre Sauvage, Sir J. Fraser Stoddart and Bernard L. Feringa “for the design and synthesis of…
According to FDA, Consumers should “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” Click here for the full story or here to learn more about OTC drug development.
PDG Has Provided Medical Device Consulting Services to Firms Around the World Since 1999 PDG offers one-stop-shopping to include 513(g) requests for information, pre-submission meetings (formerly pre-IDE meetings), IDE filing and Institutional Review Board (IRB) approvals, 510(k) and PMA submissions. Our expertise includes, clinical development in parallel with strategic regulatory planning and manufacturing and other…
Whether you are sure the product you plan to launch without FDA clearance is an exempt device or not, call PDG®. Our consultants will assist you in the compilation of a regulatory dossier to support marketing of the product to be retained with your records in case of an FDA audit. The Benefits of the…
There are a number of pre-submission meetings and review procedures available to the device industry seeking advice from FDA during the developmental stages of IDEs, 510(k)s and PMAs. PDG can help maximize the value of your interactions with CDRH through the 510(k) Pre-Submission Program, pre-IDE Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission…
To help prepare for FDA facility inspections, PDG device consultants are available to review, improve and implement quality control, quality assurance, document control, and complaint handling procedures. Improve FDA Facility Inspection Readiness with Mock FDA Audits We also prepare our clients for FDA inspections by conducting mock audits to include third party facilities such as,…