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Searching Content from United States indexed under Food, Drugs, Healthcare, Life Sciences ordered by Published Date Descending.
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1
Workplace Safety Incentive Programs And Post-Incident Drug Testing—Still Okay Under OSHA But Don't Discourage Accident Reporting
Many employers have implemented workplace safety incentive programs in an effort to reduce time lost to injuries or illness. The programs generally reward workers for reporting near-misses or hazards
United States
19 Oct 2018
2
Strategies To Unlock AI's Potential In Health Care, Part 2: FDA's Approach To Protecting Patients & Promoting Innovation
Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers?
United States
19 Oct 2018
3
FDA Regional Incident Preparedness And Response Playbook Provides Guidance To The Healthcare Industry For Large-Scale, Multi-Patient Medical Device Cybersecurity Incidents
Earlier this month, the Mitre Corporation, on behalf of the Food and Drug Administration (FDA), released the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook...
United States
19 Oct 2018
4
Give And Toke: Utah Reaches Compromise Agreement On Proposed Medical Marijuana Policy
With just under four weeks until Election Day, the push to legalize medical marijuana in Utah continues to progress.
United States
19 Oct 2018
5
CMS Proposes Tweaks To Medicare Appeals Rules To Reduce Administrative Burdens
The Centers for Medicare & Medicaid Services (CMS) has proposed revising its rules governing the process Medicare beneficiaries, providers, and suppliers.
United States
19 Oct 2018
6
CMS Proposes Requiring Prescription Drug Price Disclosure In Direct-To-Consumer Advertising
On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs...
United States
19 Oct 2018
7
NASAA Warns Investors About Marijuana-Related Investment Risks
The North American Securities Administrators Association ("NASAA") warned investors of scams and risks concerning marijuana-related investments.
United States
19 Oct 2018
8
What Are The Top Hatch-Waxman And BPCIA Developments For September 2018?
This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between "blocking patents" and objective indicia of nonobviousness.
United States
19 Oct 2018
9
TTB Publishes Updated Guidelines For Formula Approvals For Domestic Producers And Importers
On September 18, 2018, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued TTB Industry Guidance 2018-10, a webpage consisting of questions and answers related to formulas.
United States
19 Oct 2018
10
Where's The Beef?
MusclePharm produces a line of nutritional supplements, including the "Arnold Schwarzenegger Series Iron Mass" supplement.
United States
19 Oct 2018
11
New Law Requires Disclosure Of Biologic Patent Settlement Agreements To Antitrust Authorities
Last week, the Patient Right to Know Drug Prices Act ("Act") became law.
United States
18 Oct 2018
12
FDA's Drug Centers Release New Draft Guidance On Quantitative Info In Consumer-Directed Ads
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps ...
United States
18 Oct 2018
13
Trump Administration Proposes Requiring Disclosure Of Drug Prices In TV Ads
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the "Blueprint").
United States
18 Oct 2018
14
Clinical Trial Liability Revisited, Briefly
There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on the sponsor of the clinical trial.
United States
18 Oct 2018
15
HHS Secretary Suggests Listing Drug Prices In TV Ads Will Curb Consumer Costs
On October 15, 2018, in a continued effort to address rising drug costs, Health and Human Services (HHS) Secretary Alex Azar proposed that pharmaceutical companies be required
United States
18 Oct 2018
16
Case Study: Jazz Pharmaceuticals v. Amneal Pharmaceuticals
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, an appeal of six inter partes review decisions by the PTAB's finding that certain claims of seven patents ...
United States
18 Oct 2018
17
Are Non-Covered Activities And Programs At Your Campus/Institution Leaving You Overly Vulnerable To HIPAA? A "Hybrid" Designation Can Reduce Risks For HIPAA Compliance And Fines -- But Be Careful To Do It Right!
If an institution doesn't designate which functions are and are not covered by HIPAA, the assumption is that all activities fall under the HIPAA compliance umbrella.
United States
18 Oct 2018
18
Pharmaceutical Company Agrees To $625 Million False Claims Act Settlement
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
United States
18 Oct 2018
19
Four Ways To Show Nonobviousness Of ADC Inventions
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published.
United States
18 Oct 2018
20
FDA's Revised Draft Guidance On Citizen Petition Process Highlights Antitrust Risk For Filers
On October 2, 2018, the Food & Drug Administration released revised draft guidance regarding Citizen Petitions and Petitions for Stay of Action under Section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
United States
18 Oct 2018
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