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Pharmaceutical Industry › Patient Access › Clinical Trials

Morgan Lewis - As Prescribed

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Morgan Lewis - As Prescribed on

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Sunstein LLP

July 2018 IP Update: The Right to Try Act: A New Avenue for Use of Experimental Drugs

Sunstein LLP on

On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more

Verrill

Federal "Right to Try": Don't Disregard Your State Laws Just Yet!

Verrill on

How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Troutman Pepper Locke

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper Locke on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

Hogan Lovells

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Hogan Lovells

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Hogan Lovells on

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about...more

Hogan Lovells

New rules for expanded access in Italy

Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Hogan Lovells

FDA Simplifies and Clarifies Expanded Access Program

Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

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