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Reporting Requirements Pharmaceutical Industry

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

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

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

by Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

Blog: Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting...

by Cooley LLP on

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access...more

FDA Adverse-Event Reports Go Public

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

CMS Delays Expanding Medicaid Rebate Program, Price Reporting Requirements to Territories Until 2020

by Reed Smith on

CMS has announced that it is delaying until April 1, 2020 its controversial change in the definitions of “States” and “United States” included in the February 1, 2016 Medicaid covered outpatient drug final rule with comment...more

New Clinical Trial Rule Alters Reporting Requirements

by Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

by Reed Smith on

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

by Tucker Arensberg, P.C. on

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

FTC Announces Substantial Increases to Civil Penalties

by White & Case LLP on

On Wednesday, June 29, the Federal Trade Commission (FTC) announced substantial increases to the maximum civil penalties for 16 distinct violations of certain laws enforced by the FTC. Notable increases were announced for...more

Is Overreporting Adverse Event Information Always In A Company’s Best Interest?

by Arnall Golden Gregory LLP on

Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Proposed Budget Deal Would Add Medicaid Inflation Rebates for Generic Drugs

by Reed Smith on

As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes...more

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

by Holland & Knight LLP on

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

Blog: CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

by Cooley LLP on

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more

Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more

Expanded HSR Antitrust Reporting for Pharma Licensing Deals Is Here to Stay

by Proskauer Rose LLP on

On June 9, 2015, the U.S. Court of Appeals for the D.C. Circuit, in its ruling in Pharm. Research & Mfrs. of Am. v. FTC, upheld the FTC's expansion of HSR reporting requirements for pharmaceutical companies, and solidified...more

OIG Work Plan Midyear Update Adds Activities Related to Medicare Part D and Medicaid Rebates

by Pepper Hamilton LLP on

The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more

Blog: West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

by Cooley LLP on

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP)....more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

InterConnect - Winter/Spring 2015

by Benesch on

In this Issue: - Between a Rock and a Hard Place: Employers Must Walk a Narrow Path to Comply with DOT and EEOC Directives - New FDA Guidance for 3PLs on License Reporting Under the DSCSA - Moving Ahead in...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

by Cooley LLP on

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

by Cooley LLP on

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

by King & Spalding on

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

by Stinson Leonard Street on

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

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