Draft Guidance

News & Analysis as of

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

EEOC Proposes Guidance on GINA, Wellness Programs

The Equal Employment Opportunity Commission (EEOC) has followed up on proposed regulations that it issued this spring on wellness programs under the Americans with Disabilities Act (ADA) with a new set of proposed regulations...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

Comment period for FDA's draft nutrition, menu labeling guidance ends Nov. 2

On December 1, 2014, the Food and Drug Administration published its final rule on Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 FR 71156. This rule requires restaurants...more

Australian Patent Office Proposes “Coding Only” Sequence Ban

Coming soon after the High Court’s “Myriad decision” in Australia, the Australian Patent Office has proposed guidelines that would effectively limit the ban on patent-eligibility of DNA sequences to nucleic acids that code...more

FDA’s Menu-Labeling Update

Since their official unveiling in December 2014, the FDA’s final menu-labeling rules have given rise to a multitude of questions from hospitality businesses who wonder how to comply or whether they must comply at all. The...more

Oil and Gas Industry Concerned about EPA’s Proposed Methane Emissions Rules

On August 18, 2015, the EPA released proposed rules aimed at reducing methane and other volatile organic compound (VOC) emissions in the oil and natural gas industry. In January 2015, the EPA stated its goal to decrease...more

New EU Securitisation Regulation: Moving in the Right Direction

The European Commission published a draft regulation on a European framework for simple, transparent and standardised securitisation on 30 September 2015 (the “Draft Regulation”). The Draft Regulation aims to achieve a better...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Indonesia publishes data protection rule aimed at government agencies

On 14 July 2015, the Indonesian government published the Draft Regulation of the Minister of Communication and Information (RPM) of the Protection of Personal Data in Electronic Systems (‘Draft Regulation’). Pursuant to...more

DTSC Issues Guidance to Companies on How to Prepare Alternative Analysis under the Safer Consumer Products Regulations

California's Department of Toxic Substances Control (DTSC) released for comment its Draft Stage 1 Alternatives Analysis Guide (Draft AA Guide). Under the Safer Consumer Products Regulations (SCPR), responsible entities...more

Required Action on the Horizon for California Consumer Products Companies

Yesterday, the Department of Toxic Substances Control (“DTSC”) released its draft Stage 1 Alternatives Analysis Guide (“Guide”) under the California Safer Consumer Products program. Public comments are being accepted on the...more

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

ACA Menu Labeling Requirements: Draft FDA Guidance

The FDA’s 105-page final rule on chain restaurant nutrition labeling of menu items now has an associated, 53-page, draft guidance document, supplementing the FDA’s 132-page Food Labeling Guide, we learned from the September...more

European Banking Authority Shadow Banking Guidelines – Part 3: The Rationale and Context Behind the Guidelines

In the third of our series of updates on the European Banking Authority (EBA) consultation paper on the draft EBA Guidelines on limits to the exposures that EU regulated banks should have to shadow banks (the Guidelines), we...more

Guidelines for Mexico's Wholesale Electricity Market

On September 8, 2015, Mexico’s Ministry of Energy (SENER) published the Electricity Market Guidelines (the “Guidelines”) in the Federal Official Gazette. The Guidelines define and specify rules and procedures for the...more

Manatt on Health Reform: Weekly Highlights - September 2015 #2

Colorado’s uninsured rate is down 9 percentage points in four years; Michigan requests increased cost-sharing for its Medicaid expansion population above the federal poverty line; and, HHS’s proposed guidance strengthens...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

FDA Issues Draft Guidance and Proposed Rule on the Nonproprietary Naming of Biological Products

On August 28, 2015, FDA issued a draft guidance document and a proposed rule addressing the nonproprietary naming of biological products. Because nonproprietary naming can have substantial effects on the market for biosimilar...more

Draft Guidelines for Planning Grants Released by California Department of Water Resources

Guidelines Will Drive Funding Process; Comments Due Oct. 5 - With the passage of the Water Quality, Supply, and Infrastructure Improvement Act of 2014 (Proposition 1), California voters authorized the issuance of $7.1...more

Medical Device Cybersecurity: Maybe Dick Cheney Was Not So Paranoid After All

Dick Cheney famously disclosed a few years ago that he had the wireless function of his pacemaker disconnected while he was Vice President because he was concerned that hackers might fiddle with the device remotely and do him...more

What Does Operational Risk Management Draft Guideline Mean for Federally Regulated Financial Institutions?

On August 20, 2015, the Office of the Superintendent of Financial Institutions (OSFI) released Draft Guideline E-21: Operational Risk Management (Draft Guideline) for comments. With the Draft Guideline, OSFI aims to provide a...more

Federal Housing Administration Move on PACE Showcases Program’s Possible Impact

On August 24, President Obama directed the Federal Housing Administration (FHA) to allow homeowners to purchase and refinance properties with Property Assessed Clean Energy (PACE) loans when those loans are subordinated to an...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

132 Results
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.