Scott Liebman

Scott Liebman

Loeb & Loeb LLP

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FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

7/8/2016 - Clinical Trials CMS Data Collection Data-Sharing Draft Guidance FDA FDCA Final Guidance Final Rules Investigational Device Exemptions Labeling Manufacturers Medical Devices Patient-Specific Premarket Approval Applications

FDA Regulatory and Compliance Monthly Recap – May 2016

FDA draft guidance provides recommendations on use of electronic health record data in clinical trials - The draft guidance provides recommendations on deciding whether and how to use EHRs as a source of data in clinical...more

6/2/2016 - 3D Printing Clinical Laboratory Testing Data Integrity Draft Guidance EHR FDA Life Sciences Manufacturers Medical Devices Pharmaceutical Industry Recordkeeping Requirements Surveillance

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

5/3/2016 - Biosimilars Draft Guidance Drug Design FDA Food Labeling Prescription Drugs Proprietary Information Warning Letters

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

4/7/2016 - Clinical Trials FDA FDA Warning Letters FDASIA Medical Devices NIH

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

3/1/2016 - Data Collection Draft Guidance FDA FDA Commissioner Medical Devices Political Appointments Premarket Approval Applications Safety Precautions

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

2/4/2016 - Cybersecurity FDA FTC FTC v Actavis Medical Devices Misbranding OPDP Pay-For-Delay Pfizer Pharmaceutical Industry Pharmaceutical Patents Popular Product Labels Reverse Payments SCOTUS

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

1/5/2016 - Center for Drug Evaluation and Research (CDER) DOJ False Claims Act (FCA) FDA FDA Approval Food Labeling Off-Label Use Pharmaceutical Industry Prescription Drugs Qui Tam Warning Labels

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

11/6/2015 - Big Data Controlled Substances Act Cybersecurity DEA Draft Guidance FDA Labeling Medical Devices Patient Safety Pending Legislation Pharmaceutical Industry

FDA Regulatory and Compliance Monthly Recap — August 2015

OPDP warns Duchesnay over Kim Kardashian’s social media endorsement of morning sickness drug - The regulator issued a warning letter stating Kardashian’s endorsement of the company’s Diclegis pill on social media was...more

9/1/2015 - 510(k) RTA Amarin Celebrity Endorsements Draft Guidance FDA FDA Warning Letters Guidance Update Kim Kardashian Off-Label Promotion OPDP Prescription Drugs

FDA Regulatory and Compliance Monthly Recap – July 2015

FDA finalizes guidance on analytical procedures and methods validation - The regulator issued recommendations to help applicants submit analytical procedures and methods validation data to “support the documentation of...more

8/5/2015 - ANDA DSCSA FDA FDA Approval FDA Warning Letters FDCA Generic Drugs New Guidance Orphan Drugs Pharmaceutical Industry Prescription Drugs Warning Labels

FDA Regulatory and Compliance Monthly Recap – June 2015

In This Issue: - FDA draft guidance explains benefit-risk considerations for IDE applications - Allergan warned by FDA over unapproved marketing of SERI Surgical Scaffold - FDA provides guidance on...more

7/9/2015 - Allergan Inc FDA Generic Drugs Medical Devices Pharmaceutical Industry

FDA Regulatory and Compliance Monthly Recap – May 2015

In This Issue: - FDA puts out guidance to require submissions in ICH’s electronic format for certain pharmaceutical product applications within two years - OPDP warns Otsuka over improper marketing of antipsychotic...more

6/5/2015 - FDA Medical Devices Off-Label Promotion Pharmaceutical Industry Prescription Drugs

FDA Regulatory and Compliance Monthly Recap – April 2015

In This Issue: - FDA issues guidance documents on how it considers balancing premarket and postmarket data collection during PMA reviews in a bid to accelerate the approval of new breakthrough devices - Guidance...more

5/8/2015 - FDA FDCA Medical Devices Premarket Approval Applications

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

5/1/2015 - FDA Generic Drugs Orphan Drugs Otsuka Pharmaceutical Patents Pharmaceutical Industry Pharmaceutical Patents

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

4/9/2015 - Biosimilars FDA New Guidance Pharmaceutical Industry Prescription Drugs

FDA Regulatory and Compliance Monthly Recap - February 2015

FY 2016 budget request reflects FDA’s broadening scope of activities - The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7...more

3/11/2015 - Advertising Drug Compounding FDA Medical Device Accessories Medical Devices Mobile Apps Pharmaceutical Industry

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

2/4/2015 - Advertising FDA Medical Device Accessories Medical Devices Pharmaceutical Industry Regulatory Agenda Television Commercials Wellness Programs

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

1/7/2015 - Electronic Communications FDA Health Care Providers Healthcare Hospitals Labeling Pharmaceutical Industry Pharmacies Prescription Drugs Warning Labels

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

11/14/2014 - Advertising Draft Guidance FDA Health Care Providers Off-Label Promotion Pharmaceutical Industry Physicians Social Media

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

10/8/2014 - CMS Compliance Ebola FDA Medicare Medicare Part D OIG Prescription Drugs

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

9/16/2014 - Biosimilars Clinical Trials Digital Health Draft Guidance FDA Healthcare Manufacturers Medical Devices

What’s In a Name? The Value of Pharmaceutical & Biologic Branding

September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch- Waxman strove to offer consumers the benefits of “rapid...more

9/15/2014 - Biologics FDA FDCA Hatch-Waxman Pharmaceutical Industry Prescription Drugs

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

7/17/2014 - Advertising Draft Guidance FDA Health Care Providers Medical Devices Pharmaceutical Industry Popular Prescription Drugs Social Networks

FDA Releases Long-Awaited Guidances on Character Limitations and Misinformation on Internet/Social Media

In two separate guidances, the Food and Drug Administration (FDA) advises prescription drug and device manufacturers on its "current thinking" on advertising through space-constrained social media (e.g., Twitter) and on the...more

6/24/2014 - Advertising FDA Internet Marketing Prescription Drugs Social Media Twitter

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