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
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…Details
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…Details
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…Details
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…Details
Download our latest paper: What is a Biosimilar and How Does it Differ Compared to Drug Development?
Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generics are to brand-name drugs. However, there are major differences between the…Details