Subscribe to Regulations

The Lead

FDA Releases Draft Guidance on Animal Drug Compounding from Bulk Drug Substances

May 19, 2015 8:06 am | by FDA | News | Comments

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration has released its latest draft. FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.

Belief in Global Housing Standards Grows

May 14, 2015 9:33 am | by Elizabeth Doughman, Editor-in-Chief | Articles | Comments

ALN recently asked readers what aspects of housing they thought would be regulated by...

Workplace Exposure Limits for Halogenated Anesthetic Agents

April 23, 2015 9:41 am | by Brett Field | Articles | Comments

In the past 25 years, halogenated anesthetic agents, primarily isoflurane and sevoflurane, have...

Advocacy Group Recommends Policy Changes Regarding Sex Diversity in Research

February 26, 2015 8:29 am | by Elizabeth Doughman, Editor-in-Chief | News | Comments

The Georgetown Consensus Conference Work Group has offered numerous recommendations to the...

View Sample

FREE Email Newsletter

Coating the mouth with BPA-containing food, like soup, does not lead to higher than expected levels of BPA in blood, a new study shows. The study authors conclude that oral exposure does not create a risk for high exposures.

Dog Study Conclusions Debunked in Regard to Human BPA Exposure

January 30, 2015 8:32 am | by Pacific Northwest National Laboratory | News | Comments

Coating the mouth with BPA-containing food, like soup, does not lead to higher than expected levels of BPA in blood, a new study shows. The study authors conclude that oral exposure does not create a risk for high exposures.       

Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns

December 3, 2014 1:19 pm | by NIH | News | Comments

A notice has been posted to inform awardee institutions of the NIH Office of Laboratory Animal Welfare (OLAW) policy regarding animal welfare concerns shared by OLAW and the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Animal Care (AC).

Funding Opportunity for Minor Use/Minor Species (MUMS) Development of Drugs to Publish in Early 2015

November 25, 2014 10:22 am | News | Comments

The Food and Drug Administration (FDA) will publish a New Funding Opportunity Announcement (FOA) entitled “Minor Use Minor Species Development of Drugs; Research Project Grant (R01)” in early 2015. The new FOA will replace #RFA-FD-12-003, which is set to expire on January 17, 2015.


FDA Issues Recommendations for Animal Drug Sponsors

October 17, 2014 12:48 pm | by FDA | News | Comments

The U.S. Food and Drug Administration issued today draft Guidance for Industry #227: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections, with recommendations for ways animal drug sponsors can submit chemistry, manufacturing, and controls (CMC) data to the agency to improve the efficiency of the New Animal Drug Application (NADA) review process.

FDA Releases New Veterinary Feed Directive

October 14, 2014 11:29 am | by FDA | News | Comments

The Food and Drug Administration (FDA) has amended the new animal drug regulations to implement the veterinary feed directive (VFD) drugs section of the Animal Drug Availability Act of 1996 (ADAA).               

Commissioning Verification and Validation

July 23, 2014 8:29 am | by Gilles Tremblay and Spencer Andrews | Articles | Comments

One of the most critical challenges facing today’s research facilities is the acquisition of regulatory compliance—that stamp of approval that defines an institution as highly qualified, safe and desirable for the demands and challenges of complex and highly technical research.

Streamlining the Vivarium Facility Performance Verification Process

June 16, 2014 8:17 am | by Doug Kumph and Timothy Shukr | Articles | Comments

This article summarizes the process by which two vivarium facilities for a world-leading institution in Cambridge, Massachusetts were verified by the commissioning agent to be functioning properly as part of an ongoing effort to maintain accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

OLAW Change in Criteria for Renewal of Domestic Animal Welfare

May 30, 2014 10:42 am | by NIH | News | Comments

Notice of Change in Criteria for Renewal of Domestic Animal Welfare Assurances (Domestic Assurance) has been published in the NIH Guide for Grants and Contracts.                          


Health and Safety Basics: Regulatory Compliance Management

May 20, 2014 8:46 am | Articles | Comments

Animal care facilities must meet OSHA, EPA, DOT, and often accreditation agency specific standards. Non-compliance can have serious ramifications in terms of financial liability (penalties and fines), institutional reputation, and in some cases the ability to continue operations.

FDA to Retain Current Small Numbers of Animals for Minor Use in Major Species

May 19, 2014 12:22 pm | by FDA | News | Comments

The U.S. Food and Drug Administration (FDA) has announced that, following a reassessment, it will continue using the same “small numbers of animals” in a major species to determine whether an intended use of a new animal drug in a major species of animal qualifies as a minor use.

NIH to Present Changes to Manual at 2014 TurnKey Conference

March 26, 2014 8:19 am | by Elizabeth Doughman | Articles | Comments

The TurnKey Conference, held May 13–14 in National Harbor, MD, is proud to announce that senior members of the National Institutes of Health (NIH) Division of Technical Resources (DTR) will be giving a presentation on the latest updates to the Design Requirements Manual.

OLAW Updates Statement on Recent Media Coverage Related to Animals in Research

March 17, 2014 1:25 pm | by NIH | News | Comments

OLAW has updated the statement clarifying events concerning the welfare of laboratory animals that were shared recently with the media by SAEN. The update provides background information on how NIH and USDA work cooperatively to exchange information found during investigations. 

OLAW Statement on Recent Media Coverage Related to Animals in Research

March 7, 2014 12:39 pm | by NIH | News | Comments

The events concerning  the welfare of laboratory animals shared with the media by the organization Stop Animal Exploitation Now (SAEN) from January 2014 through March 6, 2014 are not current.               


TurnKey Session of the Week: Zebrafish Tour of George Washington University

February 20, 2014 12:00 am | News | Comments

The George Washington University has graciously offered a tour for a select number of participants to view a new single-lab zebrafish facility, which will be up and running in May. The tour will include discussions on the issues and hang-ups in setting up a small facility for 1-2 investigators: repurposing an existing room, facilities issues specific to fish tank racks, water quality and temperature control.

ANSI Z9.14 ANSI/ASSE Z9.14 Implications for Animal Facilities

January 24, 2014 6:18 pm | by Sheri Bernstein | Articles | Comments

A new standard, ANSI/ASSE Z9.14, was recently released. It provides a voluntary but systematic approach to evaluate safety design features, as well as operations and engineering processes and controls in high-containment laboratories and animal facilities.

Legal Issues When Managing People

November 4, 2013 4:36 pm | by Martin Seidenfeld, Ph.D. | Articles | Comments

A funny thing happens when you move into management. Like it or not, as a manager you have to deal with issues of legality. And as you go higher up the management ladder, the more pressing and ubiquitous those issues become. No, you don’t have to be a lawyer to deal with the legal issues that surround you. But you do have to be aware of specific laws and know how to make sure you aren’t violating them.

Communication Breakdown: Part 2

October 7, 2013 6:32 pm | by Vince McLeod, CIH | Articles | Comments

How do changes to Haz Comm affect you? This is the second and final installment on OSHA’s changes to the Hazard Communication standard (40CFR 1910.1200) or Haz Comm for short. Here we will discuss the details of the changes and how employers and manufacturers are affected.

Communicating Through Walls in BSL-3 and BSL-4 Facilities

October 7, 2013 6:15 pm | by John McCall | Articles | Comments

Containment can be described as the safe handling and storage of infectious materials used in laboratory research with the goals of protecting the workers inside as well as the population outside. Containment is achieved by following strict regulations and guidelines that add multiple layers of protection to the workers, the design of the physical environment, and the equipment they work with.

The Benefits of Automated Watering in Today’s Research Facility

September 9, 2013 4:56 pm | by Vicki Lanphier | Articles | Comments

At one of the United Kingdom’s most prominent medical research facilities, genetically modified mice have been safely and easily drinking from an automated watering system for several years. Housed in individually ventilated cages (IVCs) or flexible film isolators, the Medical Research Council’s (MRC) Ares Facility has automated the delivery of water to approximately 90% of their IVCs in this new building.

The Global Rise to Prominence of Ethical Oversight

September 9, 2013 4:50 pm | by Helen Kelly and Anthony James | Articles | Comments

Ethical Review is a hot topic. It is debated fiercely at forums on the future of research and ardently by members of the general public. Research professionals working in the globe’s remote corners hasten to demonstrate good faith and proclaim a genuine wish to do right by laboratory animals. Biomedical science sweats under the bright lights of high-profile controversy and image management. Anything might go viral on YouTube.

Cages Prevalent in Animal Facilities, Belief in Global Housing Standards Grows

September 9, 2013 4:42 pm | by Elizabeth Doughman | Articles | Comments

Cages are used in approximately 92% of animal research facilities, according to an August 2013 survey conducted by ALN World™, while 69.3% of respondents use racks in their facility. Aquatic equipment is used in 35.5% of the facilities, while 38.6% use isolation units.

Communication Breakdown: Part 1

September 3, 2013 8:41 pm | by Vince McLeod, CIH | Articles | Comments

Working in the safety and health field I know that OSHA rules take a long time to develop and even longer to change. But, I did not really think about how long it took or why. It’s just that in my thirty-plus years of protecting workers and watching OSHA develop new rules or try strengthening /updating existing ones I have observed that the process took a long time.

Is that Waste Hazardous?

July 2, 2013 7:31 pm | by Vince McLeod, CIH | Articles | Comments

A recent visit by state and federal inspectors brought to light the importance of knowing all your waste streams intimately. Working in a large academic research institution with all its diverse classroom laboratories, research laboratories, and support shops is quite the challenge. And sure enough, a few things slipped through the cracks, as the saying goes.

The Economic Benefits of Environmental Enrichment

July 2, 2013 7:23 pm | by Brian Wood | Articles | Comments

For more than 50 years, it has been accepted that environmental enrichment in research settings impacted brain structure, the behavior, and the health and welfare of test animals. But it wasn’t until 1996 that enrichment was even mentioned by name in the Guide for the Care and Use of Laboratory Animals.

AAALAC International Accreditation: A Catalyst and a Landmark Accomplishment for High Functioning Animal Care and Use Programs around the World

July 2, 2013 7:20 pm | by Christian E. Newcomer, VMD, MS, DACLAM, Dr. Kathryn Bayne and John F. Bradfield, DVM, Ph.D., DACLAM | Articles | Comments

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is a private non-profit organization that has now been in operation for nearly 50 years, offering a rigorous peer review accreditation program that is voluntary and confidential.

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.