Recent Blog Posts
- FDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:
Prioritize Safety of Clinical Trial Participants
Ongoing Clinical Trials. Sponsors, investigators, and IRBs should work together... More
- FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.
The Guidance recognizes the impact COVID-19 may have... More
- Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV) This is part 4 of 7 in the Medicare Secondary Payer Compliance series. All titles in this series can be viewed below. Subscribe to our blog to receive these future updates. Prior installments of this series can be accessed using the links provided.
Medicare Secondary Payer Compliance: An Introduction (Part I)
Medicare Secondary Payer Compliance: Conditional Payments (Part II)
Medicare Secondary Payer Compliance: Group Health Plans (Part III)
Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)
Medicare Secondary Payer Compliance: Providers (Part V)
- Chicago Releases Draft Rules on Pharmaceutical Representative Licensure In a previous blog post, we discussed a City of Chicago Ordinance, set to take effect on July 1, 2017, that will require pharmaceutical sales representatives to obtain a license before being able to operate within city limits. The draft rules for this ordinance were released on March 17, 2017.
These rules provide additional detail regarding the licensure requirements as well as other associated education and disclosure requirements with which pharmaceutical representatives will be expected to comply beginning in July of... More
- FDA Adopts New Designation Process for Regenerative Advanced Therapies On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act. Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.
- FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product’s approval. FDA’s guidance documents issued this week... More
- Chicago Imposes Burdensome New Licensure and Disclosure Obligations on Pharmaceutical Representatives On November 16, the City of Chicago passed an ordinance that will require pharmaceutical sales representatives to become licensed in order to promote prescription drugs to health care providers within city limits. The ordinance was passed unanimously, despite ardent objections from pharmaceutical manufacturers and industry organizations. While Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction, industry representatives characterize the license as a harmful... More
- FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board? On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.
In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders,... More
- FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of Electronic Health Record (“EHR”) data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an... More
- The Future of Research Using Electronic Medical Records Data: Precision Medicine Initiative Privacy and Trust Guiding Principles Provide Another Piece of the Puzzle One thing’s certain – the vast and growing supply of data contained in electronic medical records systems will play a significant role in improving the speed and efficiency of research into new treatments in the years to come. The challenge will be striking an appropriate balance between the unquestionable promise of this data to enable research – research that will enhance available treatments and save lives – with the rights of individual patients in the privacy of their health information. ... More