Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available here. In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements. The guidance applies to commercial manufacturing of human and veterinary drugs, certain combination products, biological and biotechnology products, finished products, active pharmaceutical ingredients, excipients, in-process materials and drug constituents of combination drug/device products.
Recently, the California Division of Occupational Safety & Health Standards Board approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in healthcare settings. The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence.
On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here.
The revised guidance finalizes the section of the document that pertains to user fees. (Note that FDA announced GDUFA user fees for fiscal year 2017 for Abbreviated New Drug Applications, Prior Approval Supplements, Drug Master Files, and facilities earlier this year (81 Fed. Reg. 49,225, July 27, 2016).) Questions and answers related to self-identification, review of generic drug submissions, and inspections and compliance, which appeared in earlier versions of this GDUFA Q&A guidance, will be updated and addressed in a separately issued final guidance.
With President-elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?
With President-Elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?
In Part One of this Health Care Counsel podcast series, Arent Fox counsel Lanhee J. Chen, a senior appointee at the US Department of Health and Human Services during the George W. Bush administration, and Senior Government Relations Director Sonja L. Nesbit, a former Obama Administration appointee who served at HHS, discussed how they expect a Trump Administration to handle Obamacare.
In the wake of the legalization of cannabis in the state of California following last week’s election, it is important for businesses to take stock of several legal issues as opportunities within this burgeoning market continue to grow. Outlined below are just a few of the areas cannabis businesses in California need to be aware of to avoid legal problems down the road.
Real Estate & Land Use
This alert was originally published on Law360.
On Nov. 8, 2016, California voters passed Proposition 64, the Control, Regulate and Tax Adult Use of Marijuana Act. The initiative legalizes recreational marijuana for individuals over the age of 21. It allows adults to possess, carry, share, transport and purchase up to one ounce of marijuana. The basic thrust of Proposition 64 is to decriminalize the adult use of marijuana for recreational purposes, as well as to regulate marijuana cultivation, distribution, sale and use.
On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US territories in the AMP and Best Price. The government’s release about the changes that were published to Medicaid.gov can be found here.
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