Scott Liebman

Scott Liebman

Loeb & Loeb LLP

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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 Manufacturers 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 Pharmaceutical Manufacturers

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 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 - Drug Manufacturers Electronic Communications FDA Health Care Providers Healthcare Hospitals Labeling Pharmaceutical Pharmaceutical Manufacturers 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11/14/2014 - Advertising Draft Guidance FDA Health Care Providers Off-Label Promotion Pharmaceutical Pharmaceutical Manufacturers Physicians Social Media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 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 Pharmaceutical Manufacturers 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

OIG Releases Semiannual Report to Congress Showing Rise in Enforcement Activities

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its Semiannual Report to Congress reporting big enforcement numbers related to its activities during the six-month period from October...more

5/30/2014 - Civil Monetary Penalty Enforcement Enforcement Actions False Claims Act Healthcare HHS OIG

Senate Committee Questions FDA's Use of Draft Guidances

In a letter to the Food and Drug Administration, a group of U.S. senators from the Committee on Health, Education, Labor & Pensions expressed "significant" concern about the agency's apparent reliance on a process of issuing...more

5/20/2014 - FDA Final Guidance Guidance Update Legislative Committees Public Comment Public Policy

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

4/29/2014 - Advertising Drug Manufacturers FDA Legal Perspectives Life Sciences Pharmaceutical Social Media Social Networks

A Spoonful of Sugar? Better Put It on the Label - FDA Issues Draft Guidance on Branding Honey

Addressing concerns about adulterated honey products, the FDA has issued draft guidance clarifying labeling requirements. According to the guidance, purveyors of honey products must specify on the product label and in the...more

4/24/2014 - Brand FDA Food Labeling

Bipartisan Group Introduces Safe and Accurate Food Labeling Act in House

In an attempt to stop the proliferation of a patchwork of state-by-state food labeling laws, and to “reaffirm” the Food and Drug Administration (FDA) as the sole authority on food safety and labeling, a bipartisan group of...more

4/22/2014 - FDA FDCA Food Labeling

@FDA Gives Little Guidance 2 #Pharma re Social Media

The way that we communicate has changed. Technology and social media have altered how we keep in touch with friends and family. Whether it is a text message that you will be late for dinner, a Tweet about breaking news, or an...more

3/12/2014 - FDA Pharmaceutical Social Media

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

3/11/2014 - FDA FDAMA Medical Devices Pharmaceutical

FDA Refusal to Define "Natural" Leaves Food Manufacturers at Risk for More and Costlier Class Action Litigation and Looking for...

The U.S. Food and Drug Administration this month declined to weigh in on the issue of whether food products containing genetically modified ingredients can be labeled as "natural," refusing the request of three federal judges...more

2/3/2014 - Class Action FDA Food Labeling Food Manufacturers Food Safety GMO

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