News

Will the FTC Match DOJ’s Efforts to Speed Up Merger Reviews?

On October 3, 2018, at a hearing before the U.S. Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights (“Hearing”), Makan Delrahim, the Assistant Attorney General for the Antitrust Division of the Department of Justice (“DOJ”), announced efforts by DOJ to “modernize and speed up the process of merger review.” Among other things, DOJ stated that it would endeavor to resolve most merger investigations within six months of filings. Relatedly, DOJ plans to make modifications to its second request process, including reforms to its timing agreements with merging parties.

Read more

Read full article

New Federal Laws Banning “Gag Clauses” in the Pharmacy

On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing reform that favors patients and consumers.

Read more

Read full article

FDA Addresses Allegations of “Gaming” The Generic Drug Approval Process Through The Use of Citizen Petitions

On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions.  Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day.  The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific reviews.

Read more

Read full article

OCR and ONC Update Their Security Risk Assessment Tool

On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool.  According to ONC and OCR, the “tool is designed to help healthcare providers conduct a security risk assessment” as required under the HIPAA Security Rule.  ONC states that the updated tool includes additional features such as:

Read more

Read full article

FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

Read more

Read full article

FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency

On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive Designs for Clinical Trials of Drug and Biologics.” This is the second of the two-part blog series describing the updates to the agency’s recommended approach to incorporating master protocols in clinical trials of new drugs and biological products for the treatment of cancer. The first of the two-part blog series described FDA’s recommended considerations to “adaptive designs” used in clinical trials.

Read more

Read full article

New Draft Guidance on Adaptive Designs for Clinical Trials

Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits.  The two draft guidances address, respectively, adaptive designs and master protocols.  This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.

Read more

Read full article

Aanbod voor een huurovereenkomst: kijk een gegeven paard niet in de bek!

De gemeente Epe heeft jarenlang een standplaatsvergunning verleend en wenst hieraan een einde te maken. Kan dit zomaar? Deze vraag werd aan het Gerechtshof Arnhem-Leeuwarden voorgelegd. Op 10 juli 2018 heeft het Gerechtshof uitspraak gedaan.

Lees verder

Read full article

How the Section 199A Proposed Regulations Would Affect Businesses

On August 8, 2018, the Internal Revenue Service (IRS) released proposed regulations (REG-107892-18) that address the operation and calculation of the 20% deduction for qualified business income (QBI) under newly enacted Section 199A of the Internal Revenue Code (the “Code”). These proposed regulations would apply to a domestic business operated as a sole proprietorship, partnership (including a limited liability company taxed as a partnership), S corporation, trust, or estate.

Read more

Read full article

HIPAA wake-up call

Physician practices, like other HIPAA-covered entities, face a daunting array of threats to their patient protected health information (PHI) and must be diligent when protecting the privacy and security of their records.

Read more

Read full article