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…

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…

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…

Orphan Drugs – Opportunities and Issues

Orphan Drugs – Opportunities & Issues

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…

505(b)(2) NDAs

Combination Drug Development and Five Year New Chemical Entity (NCE) Exclusivity

FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity. [1] FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to…

eCTD Update

A Regulatory Affairs Consultant’s eCTD Update

According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory agencies around the world.” FDA’s CDER and EMA have mandated eCTD specifications for all electronic submissions. FDA is forecasting mandates for electronic-only submissions for Abbreviated New Drug Applications (ANDA) and type II Drug Master Files (DMF), Biologics License…

As Expected, User Fee Bill Passes House Heads for Senate

The Food and Drug Administration Safety and Innovation Act (FDASIA) goes to the Senate for a vote next week after passing by a large margin in the House June 20. The new user fee legislation will result in a number of changes at FDA including generic user fees.  At the current pace, signature into law…

PDG to Attend RAPS Florida Chapter Meeting

Those of you who will be in central Florida this week are welcome to join PDG at an FDA presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media” on May 24th, 2012, 5:30–8:30 pm at the Hampton Inn and…

Prescription to OTC: PDG Attends FDA Public Hearing on Expanded Access to Nonprescription Drugs

The agency held a public hearing on March 22-23, 2012 to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.”  The hearing was preliminary with no…

PDG to Attend RAPS Florida Chapter Launch Meeting

The Regulatory Affairs Professionals Society (RAPS) has announced that several regulatory professionals in Florida are interested in launching a RAPS Chapter. PDG is pleased to inform our readers that we will be joining RAPS for the inaugural meeting to interact with other regulatory professionals from our area.  The meeting will be held in Tampa on…