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Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry [Video]

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FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7.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

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

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

FDA Simplifies and Clarifies Expanded Access Program

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

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

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

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

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

FDA Seizes Stem Cell Therapy—A First of Many?

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

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

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

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

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

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

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

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

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

To certify or not to certify? FDA has answered the question

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

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

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

A "cure" for combination products: 21st Century Cures Act mandates greater transparency of combination product designations

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

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