According to a SCOTUSblog Opinion analysis on June 12, “The Supreme Court reverses another Federal Circuit patent case… Sandoz emerged as the clear victor in the case, winning the right to bring “biosimilar” versions of complex biologic drugs to market sooner and also gaining a small but potentially important procedural right for future litigations.” FiercePharma…
DetailsJune 9 – FiercePharma reports “AMA aims at DTC ads again, this time to push inclusion of drug prices…Physicians attending the AMA annual conference in Chicago this weekend will again turn their attention to DTC ads with a new proposal to push drugmakers to list retail pricing, much like automakers do…Resolution 236 was introduced by New England medical societies from Connecticut,…
Details“The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration’s (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House. The committee also adopted several amendments to the version of the bill, known as the FDA…
DetailsFDA June 5 – FDA launched a mobile application (app) to offer access to National Drug Code (NDC) data from phones or tablets. The new app, NDC Express, presents the NDC database in a mobile-friendly format, using display and navigation features available in both Android and iOS devices. The Drug Listing Act of 1972 requires…
DetailsJune 1 – ScienceDaily Publishes “Why antibiotics fail” When a patient is prescribed the wrong antibiotic to treat a bacterial infection, it’s not necessarily the physician who is at fault. The current antibiotic assay — standardized in 1961 by the World Health Organization and used worldwide — is potentially flawed.” Here’s the full story (University of…
DetailsPDG extends its sincere thanks to DIA, Freeman, Spargo and fellow participants for making the Chicago DIA 2017 Annual Meeting a great one. We would also like to congratulate our fitbit winner, a Regulatory Affairs Director at a Central NJ pharmaceutical firm. Click here to visit DIA or here to contact PDG.
What are Complex Generics? Complex generics are those that are inherently difficult to duplicate, reviewed by CDER – OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs), are generally off-patent and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following:[1] Complex…
DetailsWhat are Complex Generics? Those that are inherently difficult to duplicate, are reviewed by CDER – OGD (not CBER), utilize the 505(j) Abbreviated New Drug Applications (ANDA) pathway, are generally off-patent, and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following: 1.…
DetailsOn Tuesday May 9, 2017 the Senate confirmed Scott Gottlieb to be the next head of the FDA. In order to provide a well rounded view of our new FDA Commissioner, we’ve provided excerpts and links to a diverse variety of stories as reported by FDA, Reuters, The New York Times, and RAPS Regulatory Focus:…
DetailsMay 15, FiercePharma reported “White House budget director suggests rebate mandates for Medicare to cut drug prices.” The story states in part that “The industry’s response was immediate and definitive in its opposition. “Any type of government price-setting in Medicare Part D would limit access to needed medicines and increase costs for beneficiaries,” PhRMA spokeswoman…
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