Draft Guidance

News & Analysis as of

USCIS on Amended H-1B Petitions for Change in Work Location

As previously reported, on April 9, 2015, the Administrative Appeals Office (AAO), which is responsible for the review of certain decisions rendered by U.S. Citizenship and Immigration Services (USCIS), issued a published...more

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...more

Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA Today

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA’s current statutory framework and regulations do not permit compounding of animal drugs from bulk drug...more

NEPA Revised Draft Guidance on Consideration of GHG Emissions: Version 2.0 - Proposal Requires Federal Agencies to Assess GHG and...

Nearly five years after issuing its initial draft, the White House Council on Environmental Quality (CEQ) continues to revise its draft guidance on conducting greenhouse gas (GHG) impact analyses under the National...more

Is There Any End to Post-Closure Care Under RCRA?

Late last month EPA issued draft guidance on adjusting post-closure periods under RCRA. It’s not good news. ...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

Update: Germany's Draft Bill on IT Security

On March 20, 2015, the revised bill to increase the security of IT systems (the "Draft Bill")was first read in the German Bundestag. As contemplated in the White & Case Technology Newsflash of August 2014, the overarching...more

USCIS Proposes: L-1B Adjudications Policy

The Key – Applying the “Preponderance of the Evidence” standard”? Immigration practitioners are trying to figure out what to make of the proposed Policy Memorandum on L-1B Adjudications Policy (hereinafter “Guidance”)...more

Protecting food industry innovations as the scope of patentable subject matter narrows

Strong intellectual property increases the value of a company. Copyrights, trademarks, patents, and trade secrets are some avenues to protect intellectual property, but understanding when they’re available and understanding...more

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

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