Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
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…
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…
DetailsLess 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…
DetailsThe 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…
DetailsMany 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“President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, March 16, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA)…While the blueprint offers little detail on what such cuts would actually mean for the agency and pharmaceutical,…
DetailsWe doubt it. However, after 6 years, FDA may be on the verge of finalizing the “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule. We called it the “Generic CBE rule” until 2014 when PhRMA and GPhA got together and proposed an alternative known as the Expedited Agency Review. That would…
DetailsFDA Voice reports that “Last year, FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research generated the highest number of approvals in the history of FDA’s generic drug program – more than 800 generic drug approvals, including both full approvals and tentative approvals. (Tentative approvals are granted to applications ready…
DetailsCiting the University of Sydney, and the Journal Nature, ScienceDaily reports that, “The warning follows a speech to Congress last week by President Trump in which he said the US Food and Drug Administration’s drug approval process was ‘too slow and burdensome,’ and where he promised to ‘slash the restraints, not just at FDA but…
DetailsFDAnews Drug Daily Bulletin reports that “After almost three years of negotiations, the U.S. and the European Union have agreed to recognize each other’s drug GMP inspections. The new pact amends the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement, to avoid duplication and cut costs for inspections”. Click here for the full but…
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