Regulatory

1. Patents Or Trade Secrets? How To Choose The Best IP Safeguard For R&D Assets 5/2/2022

   There is no one-size-fits-all answer to the question of whether to pursue a patent or trade secret, but there are guidelines available for IP practitioners in these specialized fields where R&D is a key company asset and of paramount importance to protect.

2. 4 Pitfalls To Avoid With RWE For Regulatory Submissions 4/19/2022

   Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

3. 5 Key Steps For FDA Q-Submissions 4/18/2022

   Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

4. FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs 4/14/2022

   The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.

5. Biopharma Patents: Satisfying Descriptions For Claimed Ranges 4/11/2022

   In pharma patents, ranges are often recited in patent claims to broaden the scope of the claim coverage. Claims may also include a temperature range or pH range used in making a drug. This article shares the key takeaway for industry from a recently decided court case.

6. FDA Issues Guidance On Initiation Of Voluntary Recalls 4/5/2022

   This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

7. 3 Essentials For A Fit-For-Purpose Compliance Strategy In Decentralized Pharma 4/1/2022

   In this article we discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.

8. FDA Releases Draft Guidance On Clinical Recommendations For “N of 1” Gene Therapies 3/15/2022

   To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1” (single-subject) trial, can provide crucial insight. The regulatory path for conducting such gene therapy trials has been difficult to ascertain until now. This article shares the key takeaways of the FDA's draft guidance and provides an analysis for moving forward.

9. 3 Ways The FDA Is Taking Action On Lack Of Diversity In Cancer Clinical Trials 3/3/2022

   Beyond issuing guidance documents, what actions has the FDA taken to ensure inclusion of relevant patient populations in cancer clinical trials? And what has been the impact? This article outlines three observations regarding the agency's recent efforts.

10. The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition 3/1/2022

    Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials set to come into effect in 2022, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.