Draft Guidance

News & Analysis as of

Blog: FDA Releases Draft Guidance for Reporting Adverse Events Related to HCT/Ps

The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under...more

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Now's the Time to Comment on the FDA's New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more

EU Issues Guidance to Clarify Transitional Measures for Data Requirements for Plant Protection Products and Active Substances

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FDA Issues Draft Guidance That Affects Health IT

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

New Year, New NEPA Guidance: CEQ Takes on GHGs

At the conclusion of 2014, the Council on Environmental Quality (CEQ) released revised draft guidance for federal agencies evaluating the effects of greenhouse gas (GHG) emissions and climate change as part of an...more

FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

FDA Issues Guidance for Low-Risk General Wellness Products

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

FCC to Issue Net Neutrality Rules

In February, Federal Communications Commission Chairman Tom Wheeler will circulate a draft order regarding Net Neutrality to his four fellow commissioners. The Net Neutrality rules will govern whether Internet service...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

Evaluating the Draft Amendment of the Foreign Investment Guidance Catalogue

Recently, the National Development and Reform Commission (NDRC) and Ministry of Commerce (MOFCOM) of the People’s Republic of China (PRC) jointly released a draft of the new Foreign Investment Guidance Catalogue for public...more

Australian Tax Alert: Bitcoin And Crypto-Currencies: Why The GST Law Should Change

The ATO released a draft ruling on the GST treatment of bitcoin transactions on 20 August 2014. A final version of that ruling, GSTR 2014/3, was released on 17 December 2014. While the ruling deals specifically with bitcoin,...more

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

Greenhouse Gases “Rise” in Importance for NEPA Reviews

Just before Christmas, the White House Council on Environmental Quality (“CEQ”) published revised draft guidance intended to direct federal agencies on when and how to consider the effects of greenhouse gas (“GHG”) emissions...more

Office for Human Research Protections Extends Comment Period for Draft Guidance

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance). Parties interested...more

CEQ Issues Draft Guidance on Evaluation of Greenhouse Gas Emissions

The guidance will significantly affect infrastructure projects located on federal land and federal permitting of major energy projects. On December 18, the White House’s Council on Environmental Quality (CEQ) issued...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

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