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Read need-to-know updates, commentary, and analysis on General Business issues written by leading professionals.

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

by Pepper Hamilton LLP on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Advanced Weather Data: Vital for the Future of Commercial Drone Operations

Back in December 2016, Amazon executed its first customer delivery by drone in the United Kingdom. Now, as Amazon, and other large retailers, aim for widespread deployment of drones for the delivery of goods to consumers, it...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Drone Federalism Act, Seeking Regulation of Drones at the Local Level

The Drone Federalism Act of 2017, introduced by U.S. Senators Dianne Feinstein, Mike Lee, Richard Blumenthal, and Tom Cotton, seeks to “establish a process for federal, state, local and tribal governments to work together to...more

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

The D.C. Court of Appeals Just Scrapped the Drone Registry and May Have Also Turned Homeowners Insurers into Aviation Insurers

Model-aircraft hobbyist John Taylor didn’t want to register his model aircraft with the FAA pursuant to the newly created drone registry. So he took on the FAA, challenging new regulations aimed at unmanned aircraft...more

Amazon’s Air-Traffic Control System for Package Delivery Drones

Amazon announced this week that its development of an air-traffic control system for its package delivery drones (and other commercial drones flying in the national airspace) has taken off –pun intended. This air-traffic...more

Updated Drone Statistics in the Commercial Industry

The commercial drone market is booming. While estimates certainly vary, many research firms say that the worldwide market value will rise from $2 billion today to over $10 million within the next 10 years. Similar to the GPS...more

FAA Drone/Human Collision Analysis Study Helpful for Drone Insurance

by Rumberger Kirk & Caldwell on

The FAA recently published the results of a study that was designed to evaluate the risks of serious injury to a pedestrian resulting from a drone collision. ...more

Your Business Drone Crashed... What Do You Do?

by Rumberger Kirk & Caldwell on

Understanding FAA & NTSB Drone Accident Reporting Requirements - When a corporate drone crashes, it can be one of the worst-case scenarios for owners who rely on UAS technology to conduct a wide-array of business...more

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

by Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

by Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Keeping Up with the Drones(es)

by Robins Kaplan LLP on

For the U.K., Amazon drone delivery has left the realm of fantasy and become a reality. On December 14, Amazon announced that it successfully completed its first delivery using an automated drone in Cambridge in the U.K. (In...more

Amazon’s First Drone Delivery

Amazon’s Prime Air took off on its first fully autonomous package delivery flight. While there have been many hurdles for Amazon’s drone package delivery initiative in the United States, that has not stopped them in other...more

FAA’s Drone Efforts Audited by the OIG

The U.S. Department of Transportation’s Office of Inspector General (OIG) released its recent audit of the Federal Aviation Administration (FAA), “FAA Lacks A Risk-Based Oversight Process For Civil Unmanned Aircraft Systems,”...more

FAA Sends Proposed Rule for Drone Flights over People to the White House OIRA

Recently, the Federal Aviation Administration (FAA) proposed a new rule for performance-based standards and means-of-compliance for operation of small unmanned aircraft systems (UAS or “drones’) over people who are not...more

JW Marriott and DJI, Drone-Maker, Partner Up for Drone Experience Program

JW Marriott Hotel & Resorts (Marriott) and DJI, one of the world’s largest drone makers, have partnered up to launch the hotel chain’s first Drone Experience Program; a program which will provide guests with the opportunity...more

Hackers Cause Consumer Drones to Fall from the Sky

Last week at the PacSec security conference held in Tokyo, a new device capable of fully infiltrating radio-controlled drones was unveiled by researchers. This new device exploits a vulnerability in the frequency-hopping...more

Tech & Car Companies Resist California's Proposed Autonomous Vehicle Rules

by Foley & Lardner LLP on

A who’s who of the automotive and tech sector reacted with concern at the state of California’s proposed rules for autonomous vehicles. Among other things, the companies were not happy that what the United States made...more

Picking Up Speed: DOT Releases Guidance on Automated Vehicles

New NHTSA guidance represents the federal government’s first attempt to develop a comprehensive regulatory structure for automated vehicles. This transformative technology offers vast promises and significant concerns...more

FDA Launches New Webpage to Report Regulatory Misconduct

by Stinson Leonard Street on

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

DC Circuit Finds OSHA “Interpretation” Narrowing Retail Exemption Under the Process Safety Management Standard Really a...

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In a challenge brought by trade associations for the farm supply and fertilizer industries, the D.C. Circuit vacates OSHA memorandum narrowing the retail exemption from the PSM standard. The U.S....more

NASA Announces Beyond Visual-Line-of-Sight UAS Test Flights

National Aeronautics and Space Administration (NASA) plans to fly unmanned aircraft systems (UAS; commonly known as drones) this month beyond visual line-of-sight of their operators to test planning, tracking and alerting...more

A.I. Company Flock Develops Risk Analysis Program for Drone Flights

Flock, an artificial intelligence company based in London, announced its development of a risk analysis program for commercial drones that will use real-time weather information and the location of buildings and the most...more

FAA Regs For Small Drones — A Step In The Right Direction

by Robins Kaplan LLP on

On June 21, 2016, after a long wait and much anticipation, the Federal Aviation Administration announced that it had finalized the regulations that will govern the commercial use of small unmanned aircraft systems (UAS) in...more

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