Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
In 2012, the company faced similar issues with European regulators after refusing to allow inspectors into its facilities.
Jones Day
Commission Regulation No. 490/2015/EU amending Council Regulation (EC) No 297/95 regarding the inflation-rate adjustment of European Medicines Agency fees was published on March 23, 2015.
Jones Day
The European Commission has announced plans to present a new legal framework for the authorization of GMO imports into the EU by the end of April 2015.
Jones Day
On March 19, 2015, the European Commission published guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use.
Jones Day
On March 19, 2015, the European Commission issued new guidelines on risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
Jones Day
On March 30, 2015, the European Commission published the new version of Annex 15 "Qualification and Validation" of EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
Jones Day
On March 19, 2015, the European Commission issued Commission Regulation (EU) 2015/463 of 19 March 2015, amending Annex to Regulation (EU) No 231/2012...
Jones Day
On March 12, 2015, the European Commission issued Commission Regulation (EU) 2015/414 of 12 March 2015, amending Directive 2002/46/EC of the European Parliament and of the Council...
Jones Day
On March 11, 2015, the European Commission issued Commission Regulation (EU) 2015/402 of 11 March 2015, refusing to authorize certain health claims made on foods...
Jones Day
Interest letters and nominations must be submitted by May 4, 2015.
Jones Day
Comments on the Advisory Report are now due May 8, 2015.
Jones Day
In the April 9, 2015, Federal Register, USDA requested nominations to fill five upcoming vacancies on the National Organic Standards Board ("NOSB").
Jones Day
These measures, which encompass restrictions in use and dose, will be directly implemented by the Member States where the medicines are authorized, according to an agreed timetable.
McGuireWoods LLP
This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute Bundling.
Morrison & Foerster LLP
On April 7, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Astrazeneca AB v. Apotex Corp., affirming an award of a reasonable royalty of 50% in a case arising from the Hatch-Waxman Act.
McGuireWoods LLP
Health Diagnostics Laboratory (HDL) of Richmond, Va., has agreed to pay $47 million to resolve allegations it violated the False Claims Act by compensating physicians for ordering tests, according to a U.S. Department of Justice news release.
McGuireWoods LLP
Livongo Health has announced it has secured $20 million in series B funding.
Jones Day
In the April 9, 2015, Federal Register, FDA announced its proposal to amend regulations for registration of foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States.
Jones Day
Late last month, FDA announced its strategy to create definitions and standards of animal food ingredients in order to increase transparency and affirm the safety of the animal food supply.
Day Pitney LLP
The "Emergency Medical Services and Surprise Bills" law ("Surprise Bill Law") that went into effect in New York on March 31, 2015 imposed a complex set of required disclosures on healthcare providers.
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Fox Rothschild LLP
Last week, the IRS issued its "final" versions of the forms 1094-B, 1094-C, 1095-B and 1095-C along with instructions for the "B" forms and instructions for the "C" forms.
Foley & Lardner
A group of bipartisan, bicameral congressional leaders introduced a bill, on March 19, to repeal the Sustainable Growth Rate formula that governs Medicare physician payment rates.
McDermott Will & Emery
More than 80 percent of all deals in the pharmaceutical industry include an earnout structure that provides some type of contingent or delayed payment of proceeds to the sellers.
Morgan Lewis
Ahead of finalizing FDAs tobacco products "deeming" rule, the FTC considers taking enforcement action against e-cigarette firms for violative advertising, marketing, and sales practices.
Jones Day
We hope you enjoy this, our first of many legal updates on notable happenings affecting digital health, mobile health, and telemedicine.
Fox Rothschild LLP
As of todays date, Congress has not yet fixed or even patched the expected 21% cut to the Medicare Physician Fee Schedule.
Jones Day
The Americans with Disabilities Act of 1990 ("ADA") authorizes employers to conduct medical examinations and to obtain employee medical histories as part of wellness programs as long as participation by employees is voluntary.
Fox Rothschild LLP
Electronic medical records provide a multitude of benefits for providers and patients by promoting efficient record access, cost savings and better patient care. So what's the down side?
Fox Rothschild LLP
Our partner Elizabeth Litten and I were quoted by our good friend Marla Durben Hirsch in her recent article in Medical Practice Compliance Alert entitled "Doctor is Arrested for Stealing Thousands of Patient Records."
Proskauer Rose LLP
Continuing its focus on so-called "premium reimbursement" or "employer payment plans", the Internal Revenue Service (IRS) released IRS Notice 2015-17 on February 18, 2015.
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