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On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."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
Yesterday, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and...more
On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more
5/25/2018
/ Biotechnology ,
Deregulation ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
Patient Access ,
Patient Referrals ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Burden ,
Regulatory Reform
On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more
5/14/2018
/ Commercial Marketing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Patient Safety ,
Pharmaceutical Industry ,
Regenerative Medicine ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological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
FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. ...more
Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...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 the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more
9/21/2017
/ CGMP ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Health Care Providers ,
Inspection Rights ,
Life Sciences ,
Medical License ,
Pharmaceutical Industry ,
Safety Standards ,
Stem cells ,
Warning Letters
Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more
On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
8/22/2017
/ Abbreviated New Drug Application (ANDA) ,
Biotechnology ,
Drug Design ,
Drug Pricing ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Medical Devices ,
New Legislation ,
Orphan Drugs ,
PDUFA ,
Pediatrics ,
Prescription Drugs ,
Product Labels ,
Regulatory Oversight ,
Trump Administration ,
User Fees
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 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...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 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
The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more