PDG 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: Complex…Details
What 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.…Details
On 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:…Details
May 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…Details
According to FDA on May 2, “A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially road maps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has…Details
WorldPharmaNews reported on May 12 that “Alzheimer’s experts call for changes in FDA drug approval standards”: “Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease,” urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new…Details
On April 24, 2017, Health Canada reported that “In efforts to stay aligned with other regulatory authorities, in July of 2016, Health Canada announced January 1st, 2018 as the proposed date for mandatory filing of specified regulatory activities in eCTD format. This notice serves as a confirmation of this date…Please be advised that exemption from…Details
The DIA 2017 Annual Meeting will be held in Chicago June 18-22. If you plan to be there, be sure and stop by booth 1245. Here’s a link to the meeting details, as well as a link to our contact page in case you would like to meet with us.
On March 31 2017, FDAnews Drug Daily Bulletin reported that “EMA Requests Suspending Sales of Hundreds of Drugs Due to Flawed Data from Indian CRO…The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic…Details