By Daniels Porco & Lusardi, LLP | Published January 11, 2018 | Posted in Health Care Law | Tagged Tags: Health Care Law | Comments Off on Is FDA Hiding Behind Guidance Docs To Circumvent Formal Rulemaking?
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Is FDA Hiding Behind Guidance Docs To Circumvent Formal Rulemaking?
The process applicable to formal rulemaking engaged in by federal agencies is lengthy and laborious. A recent Bloomberg article discussing how ideas turn into final administrative rules describes it as “cumbersome.” No one likely knows that better than principal employees of the U.S. Food and Drug Administration. The FDA is an agency that is routinely Read More
Read MoreRegulatory Processes Ongoing Shifting In Health Care Industry
Given the bottom line linked with human lives and patient safety, it is hardly surprising that the health care realm is one of the most tightly regulated industries in the world. In the United States, of course, it is the U.S. Food and Drug Administration that plays an especially close and exacting rule in ensuring Read More
Read MoreHealth Care Fraud Penalties Wide Ranging And Significant
Conscientious health care providers across New York — doctors, nurses, pharmacists, lab technicians and others — routinely think about care quality and how to best ensure that their patients are receiving it. While doing so, though, they are also focused on an additional matter these days that has nothing to do with patient outcomes and Read More
Read MoreImplications For Sure If Amazon Enters Pharmacy Market In Big Way
Health care “is complicated,” stresses a recent New York Times article. And, notes that piece, a potential new industry player might soon be coming to grips with just how utterly complex the hoops and hurdles relevant to that huge chunk of the economy can be. Notwithstanding the regulatory exactions — authored by local, state and Read More
Read MoreMany States Continue To Expand Medicaid Benefits
A recent study has shown that several states have expanded or enhanced their Medicaid benefits this year, with several planning to do so next year. The increased benefits were primarily for mental health treatment and substance abuse. Some of the other treatments that saw expanded benefits include telemedicine, dental care, oral contraceptives, and cancer screenings. Read More
Read MoreWhat Is The New York Office Of Professional Medical Conduct
There is a strong reason why a New York doctor or physician’s assistant might want to turn immediately for help to a proven doctors’ rights law firm following receipt of an adverse communication — indeed, virtually any communication — from the New York Office of Professional Medical Conduct (OPMC). In fact, there are lots of Read More
Read MoreFda Pharmaceutical Company At Odds Over Well Known Allergy Shot
Daniels, Porco & Lusardi, LLP, is a New York health care law firm that traces its roots back decades and has collective on-point experience over relevant client matters that spans well more than a century. As such, the firm’s attorneys candidly know a thing or two about the close regulatory scrutiny that health care-related businesses Read More
Read MoreYes, Regulation Impacts Health Care: Dealing With The Future
Carole Faig, a regulatory expert focused on health care matters, concedes the sheer challenges and uncertainty that American medical industry actors routinely face as they seek to promote health and simultaneously prosper. It’s just a given, she says, and something that care principals — “CEOs and other leaders in the health space” — must simply Read More
Read MoreLicenses Granted By Doh To Five New Medical Marijuana Firms
The New York State Department of Health made headlines earlier this week when it announced that the cultivation, production and sale of medical marijuana was going to be greatly expanded moving forward with the granting of licenses to five new firms. The move, which brings the number of “registered organizations” licensed to take part in Read More
Read MoreScrutiny On FDA Following New Study On Drug Warnings
As we have duly noted in prior select posts, many individuals and enterprises operating within the health care realm in New York and nationally are routinely under intense public and regulatory scrutiny. And among all those industry participants, there is perhaps no other entity so closely perused as the U.S. Food and Drug Administration, especially Read More
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