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Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

More Than a Family Affair: Six-Figure HIPAA Penalty Upheld for Unrepentant Home Care Agency due to PHI Access by Spurned Spouse of...

The Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 and the regulations promulgated thereunder (“HIPAA”) should be now well-known to health care providers and health plans. Under HIPAA’s...more

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

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

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...more

The US Biosimilars Pathway: Key Questions

In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more

Second CMP Assessed for HIPAA Violations: Do You Know Where Your Data Is?

For only the second time in its history, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed a civil money penalty (CMP) on a covered entity for allegedly violating the HIPAA...more

New Ruling Challenges FTC Authority to Regulate Cybersecurity Based on “Possible Consumer Harm”

A Nov. 13, 2015 ruling supports the argument that various companies and lawyers have been making for years: the Federal Trade Commission is exceeding its authority in prosecuting cybersecurity breaches under Section 5 of the...more

FDA Medical Device Approval Rate Hits 15 Year High

According to a Food and Drug Administration 2015 performance report, the FDA’s approval rate for high-risk medical devices jumped to 98 percent for medical devices submitted within the most recent fiscal year. This was a 12...more

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Spectranetics Announces FDA Approval for Turbo-Power™ Laser Atherectomy Catheter Device

According to a recent press release, Colorado Springs-based Spectranetics announced that it has received FDA 510(k) clearance for its Turbo-Power™ Laser Atherectomy Catheter, a peripheral atherectomy product used to treat...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Company Prevails in Challenge to FTC Data Security Complaint

A recent decision by the Federal Trade Commission (FTC) Chief Administrative Law Judge (ALJ) dismissed the FTC’s complaint against LabMD, Inc. (LabMD) asserting the company’s alleged failure to protect consumer data in two...more

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

FTC Theory of Unrealized Consumer Injury Rejected in LabMD Data Security Case

In what could be a major setback for the Federal Trade Commission (FTC) in the data security arena, an Administrative Law Judge (ALJ) has ruled that an unfairness claim brought by the FTC under Section 5 of the FTC Act...more

FDA Rejects Hospira’s EPO Biosimilar Application

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more

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