News & Analysis as of

IRB

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

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

Financial Regulatory Observer - September 2017: Calculation of risk-weighted credit exposures

by White & Case LLP on

Regulators are trying to bring consistency in calculating risk-weighted assets, casting further doubt on the use of internal models by financial institutions. The Capital Requirements Regulation (CRR) requires credit...more

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

by Hogan Lovells on

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

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

What Are the New 2018 Health Savings Account Limits?

by McDermott Will & Emery on

In Revenue Procedure 2017-37, 2017-21 IRB, the IRS issued the annual inflation-adjusted contribution, deductible and out-of-pocket expense limits for 2018 for HSAs. For clear comparison, we have outlined the changes from 2017...more

Bank of England Publishes Consultation on Internal Ratings Based Approach

by Shearman & Sterling LLP on

The Prudential Regulation Authority has published a consultation paper outlining the Prudential Regulation Authority's proposed changes to the Internal Ratings Based approach...more

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

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

by Hogan Lovells on

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

HHS Finalizes Toned-Down Version of Common Rule Overhaul

by McDermott Will & Emery on

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

Better Healthcare Newsletter from Patrick Malone - December 2016

Give a lasting holiday gift of health: Volunteer for a medical research study - That toy the kids whined about for weeks may be broken hours after emerging from the box. The gift card you gave will be frittered away,...more

European Banking Authority Publishes Final Guidelines on Application of Definition of Default 

by Shearman & Sterling LLP on

The European Banking Authority published the final Guidelines specifying the application of the definition of default in relation to the Internal Ratings Based Approach and the Standardized Approach under the Capital...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

FDA Streamlines the Expanded Access Approval Process for Individual Patients

by Arnall Golden Gregory LLP on

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more

FDA Issues Guidance on Expanded Access Use of Investigational Drugs

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

by BakerHostetler on

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

UK Financial Regulatory Developments - May 2016 #6

by Dentons on

Industry associations agree cyber principles - ISDA, the European Banking Federation and the Global Financial Markets Association have published a set of common principles they hope will encourage effective global policy...more

Basel Committee on Banking Standards Proposes Amendments to the Internal Rating Based Approach

by Shearman & Sterling LLP on

The Basel Committee on Banking Standards launched a consultation on changes to the advanced internal ratings based approach and the foundation IRB approach so as to reduce variation in capital requirements for credit risk...more

UK Financial Regulatory Developments - February 2016 #10

by Dentons on

EBA publishes MCD passporting compliance table - EBA has published a table noting the compliance status of Member States in relation to EBA’s guidelines on passport notifications for credit intermediaries under the...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

by Arnall Golden Gregory LLP on

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

PRA updates statement on IRB approaches

by Dentons on

PRA has updated its supervisory statement on internal ratings based (IRB) approaches to credit risk. It has removed expectations now superseded because of actions by the Commission. The updates made include: - deleting...more

What To Do About Junk Science That’s Published?

by Reed Smith on

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

EBA consults on harmonised definition of default

by Dentons on

EBA is consulting on draft guidelines under the Capital Requirements Regulation (CRR) to harmonise the definition of default across the EU prudential framework, which is intended to bring consistency in the way EU banks apply...more

Prudential requirements supplements in OJEU

by Dentons on

Delegated Regulations relating to Regulatory Technical Standards (RTS) under the CRR have been published in the OJEU. These concern: - forms for disclosure of information in relation to the compliance of institutions...more

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