Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
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…
On 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…
On 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…
Less than a month before eCTD submissions of drug and biologic master files were to become mandatory, FDA announced that it had postponed the requirement: “NOTE: On April 7, 2017 the FDA announced that it is extending the compliance date for submitting DMFs in eCTD format to May 5, 2018. These webinars were created prior…
The notice published in the Federal Register on April 7, 2017 is summarized as follows: “The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures…