Draft Guidance

News & Analysis as of

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

BVI publishes draft FATCA Guidance Notes

In the latest moves towards implementation of the FATCA Intergovernmental agreements (IGAs) signed by the BVI with the US and the UK, the BVI Government has released draft Guidance Notes for public consultation. A copy can be...more

Department of Education Issues Guidance on Changes to Clery Act Reporting Procedures and Requirements

On July 14, 2014, the U.S. Department of Education (DOE) issued important guidance to colleges and universities on their responsibilities to comply with changes to the Clery Act made by the amendment to the Violence Against...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar.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

Sugar and Spice and Cases on Ice: Evaporated Cane Juice Case Stayed Until FDA Issues Formal Guidelines

Last week, a California federal judge revived a putative class action accusing Amy’s Kitchen Inc. of misleading customers by labeling sugar as “evaporated cane juice” on its products. In a finding that puts the case on hold...more

Financial Regulatory Developments Focus - July 2014 #2

In this issue: - Derivatives - Regulatory Capital - Recovery & Resolution - Financial Services - Consumer Protection - Enforcement - People - Events -...more

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more

FDA Issues Draft Guidance Eliminating Regulatory Controls on Medical Device Data Systems, Imaging Storage Devices, and Imaging...

On June 20, 2014, the United States Food and Drug Administration (FDA) issued a draft guidance document announcing that the agency does not intend to enforce the general regulatory controls applicable to medical device data...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

FDA Issues Draft Guidance on Promotion on Internet and Social Media Platforms

On June 17, 2014, the FDA issued long-awaited draft guidance documents addressing two challenges related to use of social media to communicate about FDA regulated products: dissemination of information in character-limited...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within...more

FDA Issues Final and Draft Nanotechnology Guidances

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in...more

FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems

In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image...more

FDA Issues Draft Guidances Regarding Social Media: Handling Misinformation and Character Space Limits

On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms:...more

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

FDA Publishes New Draft Guidance on Biosimilars As Congress Raises Questions About FDA’s Use of Draft Guidance Documents

As we previously reported, the U.S. Food and Drug Administration (“FDA”) has been drafting guidance regarding the regulation of biosimilars since as early as 2011. A biological product is biosimilar if it is “highly similar...more

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