James S. Cohen

James S. Cohen

McDermott Will & Emery

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FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

7/2/2015 - Drug Manufacturers DSCSA Enforcement FDA Pharmaceutical Manufacturers Prescription Drugs Supply Chain

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

4/30/2015 - Clinical Trials FDA Investigational Device Exemptions Medical Devices Premarket Approval Applications

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

3/26/2015 - Clinical Trials FDA HHS Informed Consent Medical Research Pharmaceutical Scientific Research

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

3/20/2015

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

2/12/2015 - FDA Final Guidance Healthcare Medical Device Accessories Medical Devices

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

2/5/2015 - Draft Guidance FDA Medical Device Accessories Medical Devices

Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more

12/11/2014 - Africa Anti-Spam Legislation Canada China Cybersecurity Data Protection EU EU Data Protection Laws FTC Latin America Legislative Agendas

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

7/22/2014 - Advertising FDA Internet Medical Devices Prescription Drugs Social Media

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

6/26/2014 - Digital Health Enforcement Exemptions FCC FDA Healthcare ONC

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

6/18/2014 - Draft Guidance Drug Manufacturers FDA Health Safety Pharmaceutical Reporting Requirements

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

4/10/2014 - FCC FDA Health Information Technologies Medical Devices ONC

HHS and GAO Reports Highlight Need to Address Drug Shortages

Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively, focus on the impact of prescription drug shortages, their potential causes...more

3/26/2014 - FDA GAO HHS Pharmaceutical Prescription Drugs

FDA Releases Final Guidance on “Dear Doctor” Letters That Omits Controversial Behavior Modification Assessment Provision

On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters. While the finalized guidance modifies and removes certain controversial provisions from the...more

2/27/2014 - FDA Healthcare Prescription Drugs

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

1/29/2014 - Biologics FDA Internet Marketing Prescription Drugs

New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act addresses two hot-button issues relating to marketed drug products: the extent of federal...more

1/22/2014 - Drug Compounding FDA Pharmaceutical Pharmacies Prescription Drugs

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

5/7/2013 - Biosimilars FDA Fees Meet and Confer Sponsors

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

12/11/2012 - FDA Off-Label Promotion Pharmaceutical

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