Medmarc Blog (blog.medmarc.com)
Pharmaceuticals
FDA’s Drug, Biologics Centers Release Primary Bayesian Guidance
The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...
FDA Unveils Voucher Program for High Priority Therapeutic Products
The FDA has established a new priority review program for premarket applications for pharmaceuticals that reflects the agency’s health priorities. Under this program, the premarket review process...
FTC Seeks to Remove Medical Patents from FDA’s Orange Book
The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...
FDA Reissues CRL Guidance for Generic Drugs After Five Months
The FDA has reissued a July 2022 guidance for complete response letters (CRLs) for generic drug applications after only five months, although the December 2022 version was made necessary by the...
Congress Passes Budget Omnibus without VALID Act
The U.S. Senate and House of Representatives have concluded their work on the budget for fiscal year 2023, sending the Consolidated Appropriations Act (CAA) to the White House for President...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
Congress Passes FDA User Fee Legislation
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"
The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the...