Device Pre-submission Meetings and Reviews with CDRH

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…

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FDA Facility Inspections - Readiness and Mock FDA Audits

FDA Facility Inspections – Readiness and Mock FDA Audits

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,…

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Combination Device and Drug/Biologic Submissions

Generally speaking, a combination product is composed of any combination of a device/drug, device/biologic, drug/biologic or combination of all three, including co-packaged products. Combination products are often confused with fixed combination dose (FCD) drug products, which are comprised of drug/drug combinations. Because PDG’s team of device consultants and pharmaceutical consultants possess industry expertise in the…

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Florida Based Medical Device Consultant on 510(k) Submissions

Florida Based Medical Device Consultant on 510(k) Submissions

As a medical device consultant, PDG takes great interest in the ever-changing landscape of the premarket notification (510(k)) review and clearance process.  Besides the significant scrutiny given to the program over the past five years, the vast majority of legally marketed medical devices in use in the U.S. today were cleared via the 510(k) regulatory…

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Pharmaceutical Consultant’s Update on Smoking Cessation and Generic Drug Safety Surveillance

As pharmaceutical consultants with a long history of work in smoking cessation and safety surveillance, PDG® is monitoring two pending proposed rules with great interest. The first is entitled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations…

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New Pregnancy Drug Labeling Rules Take Effect (white paper)

New pregnancy labeling rules for prescription drugs took effect, June 30, 2015, marking the demise of the pregnancy categories (A, B, C, D, X), in use since 1979. The new rule ushers in what is expected to be an unprecedented era of inclusion regarding descriptive risk and benefit information. According to FDA, “a narrative structure…

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Proposed Generic Drug Labeling “CBE” Rule Turned on its “EAR”?

Changes Being Effected (CBE) As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. We even gave it our own abbreviated name: the “Generic CBE Rule”. We did so because the rule as originally proposed would allow generic manufacturers to implement safety…

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US Pharmaceutical Consultant on India’s Pharmaceutical Industry and the Decline of the Patent Cliff

India’s Pharma Industry Faces Unprecedented Challenges  India’s pharmaceutical industry has grown at record levels in recent years but now faces unprecedented challenges as the number of blockbuster drugs scheduled to go off patent begins to decline. As Indian pharma has expanded ANDA filings in line with the patent expiration cycles over the last decade, the…

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