Administrative Law, Health Law, Science, Computers & Technology

China FDA Announces Key Appointments and Restructuring Plan

by Katherine Wang | Ropes & Gray LLP on 5/21/2013

Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug...more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

by James S. Cohen, Glenn Engelmann, Michael Ryan | McDermott Will & Emery on 5/7/2013

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Compounding Animal Drugs from Bulk Ingredients

by Duane Morris LLP on 4/17/2013

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

FDA Emphasizes Patient-Specific Prescriptions

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 3/21/2013

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

by Frederick Ball, Elinor Hart, Michael A. Swit | Duane Morris LLP on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

by Rachael G. Pontikes | Duane Morris LLP on 2/26/2013

In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

by King & Spalding on 2/7/2013

In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

by King & Spalding on 2/4/2013

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

HIPAA Omnibus Final Rule - What's in it for Patients?

by The Harlow Group LLC on 2/1/2013

The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a...more

Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement

by Dianne Bourque, Stephanie Willis | Mintz Levin - Privacy & Security on 1/18/2013

The final regulations from Department of Health and Human Services Office of Civil Rights (OCR) containing modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (Omnibus Rule) have finally...more

Health Law Blog: Final HIPAA Rules Released

by Susan J. Freed | Davis Brown Law Firm on 1/18/2013

Yesterday, the U.S. Department of Health and Human Services (HHS) released the long-awaited final rules implementing changes to the HIPAA privacy and security rules enacted in 2009 by the HITECH Act....more

The HIPAA/HITECH Final Rule Has Been Released

by Theodore Kobus III | BakerHostetler on 1/18/2013

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

by Elizabeth Johnson | Poyner Spruill LLP on 1/18/2013

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

Hospitals Need To Focus On Data Privacy And Security

by Michael Volkov on 1/18/2013

To restate the obvious, hospitals operate in a risky environment. They face a variety of risks and a blanket of government regulations. You have to admire the Chief Compliance Officer at a hospital. They learn to live with...more

Hospitals Need To Focus On Data Privacy And Security

by Michael Volkov on 1/18/2013

To restate the obvious, hospitals operate in a risky environment. They face a variety of risks and a blanket of government regulations. You have to admire the Chief Compliance Officer at a hospital. They learn to live with...more

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

by Katherine Wang | Ropes & Gray LLP on 1/18/2013

On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more

First HHS OCR Settlement for HIPAA Breach Involving Less Than 500 Patients Sends Message to Providers

by King & Spalding on 1/15/2013

On January 2, 2013, HHS announced that the Hospice of North Idaho (HONI) agreed to pay $50,000 and enter into a Corrective Action Plan (CAP) as part of a settlement involving a breach of unsecured electronic protected health...more

CMS Seeks Comments on Hospital Readiness for EHR Hospital Inpatient Quality Data Reporting

by King & Spalding on 1/15/2013

CMS is seeking comments from hospitals, electronic health record (EHR) vendors, and other interested parties regarding whether hospitals could be ready as early as January 1, 2014, to electronically report patient-level...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

by Erin M. Bosman, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 1/15/2013

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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Administrative Law › Health Law › Science, Computers & Technology

China FDA Announces Key Appointments and Restructuring Plan

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

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

Compounding Animal Drugs from Bulk Ingredients

FDA Emphasizes Patient-Specific Prescriptions

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

FDA Issues Final Rule Regarding CGMPs for Combination Products

HIPAA Omnibus Final Rule - What's in it for Patients?

Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement

Health Law Blog: Final HIPAA Rules Released

The HIPAA/HITECH Final Rule Has Been Released

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

Hospitals Need To Focus On Data Privacy And Security

Hospitals Need To Focus On Data Privacy And Security

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

First HHS OCR Settlement for HIPAA Breach Involving Less Than 500 Patients Sends Message to Providers

CMS Seeks Comments on Hospital Readiness for EHR Hospital Inpatient Quality Data Reporting

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Audits, Audits And More Audits: Life In The Healthcare Industry

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

Chinese FDA Unveils Plan for Regulatory Reform

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

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