Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” ...more
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."
...more
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more
Right-to-try laws and the future of access to investigational treatments -
The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more
2/15/2018
/ 21st Century Cures Initiative ,
Biopharmaceutical ,
Biotechnology ,
Clinical Trials ,
Expanded Access Programs (EAPs) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Right to Try
State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about...more
Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more
On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more
In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
6/14/2017
/ Abbreviated New Drug Application (ANDA) ,
Certification Requirements ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Guidance Update ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Standards
On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
2/13/2017
/ 21st Century Cures Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRB ,
NPRM ,
Scientific Research ,
The Common Rule