Generic Drug Consulting More Relevant Now Than Ever

Generic Safety Surveillance, Pharmacovigilance and Labeling Consulting Could Be More Relevant Now than Ever

Regulatory Affairs, Research & Development

PDG™ is comprised of pharmaceutical consultants who devote considerable resources to brand and generic post-marketing safety surveillance, pharmacovigilance and labeling supplements. On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using the Changes Being Effected (CBE) and Prior-Approval Supplement (PAS) procedures (among…

Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

Medical Device Consulting News, Pharmaceutical Consulting News, Regulatory Affairs, Research & Development

What is an Adaptive Clinical Trial? Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design. Gaining in popularity since the early 1990s,[1] adaptive trials are those which observe patient outcomes after review of interim data and accommodate modifications to trial and/or statistical procedures.[2] [3] [4] Compare such trials…

Florida Based Medical Device Consultant on 510(k) Submissions

Florida Based Medical Device Consultant on 510(k) Submissions

Medical Device Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, 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…

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

Labeling / Marketing, Medical Device Consulting News, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Safety & Pharmacovigilance

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…

New Pregnancy Drug Labeling Rules Take Effect (white paper)

Labeling / Marketing, Pharmaceutical Consulting News, Quality Assurance & Compliance, Regulatory Affairs, Regulatory Updates, Safety & Pharmacovigilance

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…

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

Labeling / Marketing, Pharmaceutical Consulting News, Quality Assurance & Compliance, Regulatory Affairs, Regulatory Updates, Strategic Drug Development, Submissions

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…

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

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Updates, Research & Development, Strategic Drug Development

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…

PDG: A Pharmaceutical Consultant on Drug Reformulations

PDG: A Pharmaceutical Consultant on Drug Reformulation

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

As a pharmaceutical consultant, PDG understands that today’s drug manufacturers rely upon reformulation to prolong product lifecycles, protect against generic competition, supplement dwindling pipelines and otherwise differentiate/repurpose existing drug products. Indeed, novel formulations and drug delivery-based product development strategies have the potential of yielding higher returns on investment than comparable repositioning strategies. The Value of…

Rx-to-OTC Switches Represent Huge Market Potential

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or OTC) drug space represent huge market potential. A Strong Domestic OTC Market The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion. [1] By the beginning of 2014,…

Orphan Drugs – Opportunities and Issues

Orphan Drugs – Opportunities & Issues

Labeling / Marketing, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

Orphan Drugs Offer Revenue and Profit Upside Many have speculated that the era of the blockbuster drug has ended. Indeed, 2014 marked the 6th year of a patent cliff in which a majority of U.S. blockbusters fell to generic competition. [1] Patent cliff notwithstanding, of the 43 global blockbusters on the market in 2012, 18…