Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
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.…
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…
DetailsAccording 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…
DetailsWorldPharmaNews 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…
DetailsOn 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…
DetailsThe 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…
DetailsOn Tuesday, April 4, 2017, Fierce BioTech reported “New House bill to add 35% tax credit for contracted research…A bipartisan bill that plans to allow a tax credit for expenses of contracted research—often done by CROs—has been introduced in the U.S. House of Representatives and was quickly hailed by the industry. The H.R. 1234 bill, also referred…
DetailsOn April 7, 2017 FDAnews Drug Daily Bulletin reported that “Fiscal 2017 could be a record-setting year for ANDA applications if trends continue. Following a wave of ANDAs in December 2016, the number of applications received by the FDA is up by 50 percent over the same point in fiscal 2016 — already matching the…
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