FDA Archives - Page 70 of 73

Outcomes data enters the 21st century

Data, FDA, FDA/Regulatory, February 2017, Hospitals, Issue Archives, Pharmacy Benefit Managers

A lot can happen in 20 years. When the FDA Modernization Act (FDAMA) was passed in 1997, a mere 217 of its ~40,000 words were allocated to the presentation of healthcare economic information (HCEI). Those 217 words resided within Section 114 of the Act, giving birth to the abstract universe many of us now commonly refer to as FDAMA 114. Fast-forward to January 2017, and the FDA’s release of its Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance for Industry and Review Staff. Now 7,000+ words, this document is likely to significantly alter the way pharmaceutical manufacturers engage with the audience who increasingly holds the keys to its commercial success … payers such as health plans, pharmacy benefits managers (PBMs) and hospital systems.

February 14, 2017/by Administrator

The brave new world of healthcare in America: Trump’s impact

Coalition for Healthcare Communication (CHC), Congress, Donald Trump, DTC, FDA, FDA/Regulatory, February 2017, Healthcare Communications Agencies, Healthcare Communications Networks, Issue Archives, John Kamp, Medicaid, Obamacare

The Coalition for Healthcare Communication (CHC) summit in Washington, D.C., in late November provided an interesting postmortem of the 2016 election, and a look into the crystal ball by some of our industry’s most knowledgeable leaders. Fast-forward to February 2017, and the crystal ball is still pretty cloudy.

February 14, 2017/by Administrator

FDA Approves Two Teva Asthma Inhalers

Approvals, Asthma, Blockbusters, FDA, FDA/Regulatory, Generics, Health, Inhalers, Respiratory

Teva Pharmaceutical Industries Ltd. announced FDA approval of two products for adolescent and adult patients with asthma: AirDuo RespiClick and ArmonAir RespiClick.

January 30, 2017/by Business Wire

Aurobindo Receives FDA Approval for Dalfampridine Extended-Release Tablets, 10 mg

Abbreviated New Drug Applications (ANDAs), Approvals, FDA, FDA/Regulatory, Generics, IMS Health, Multiple Sclerosis

The U.S. FDA granted final approval to Aurobindo Pharma Limited’s generic treatment for multiple sclerosis.

January 25, 2017/by Administrator

Eagle Pharmaceuticals Completes NDA Submission for Ryanodex for Exertional Heat Stroke to FDA

Exertional Heat Stroke (EHS), FDA, FDA/Regulatory, New Drug Application (NDA), PDUFA

Eagle Pharmaceuticals Inc. announced that it has completed the submission of its 505(b)(2) New Drug Application for Ryanodex for the treatment of exertional heat stroke (EHS) to the U.S. Food and Drug Administration.

January 23, 2017/by Business Wire

Healthcare Agency Roundtable 2016

December 2016, Donald Trump, DTC, FDA, FDA/Regulatory, Generics, Health Insurance, Health Insurers, Interactive & Digital Marketing, Issue Archives, Marketing & Advertising, Obamacare, Personalized Medicine, Pricing, Special Reports, Technology, Therapeutics

Management from 2016 Manny Award winners and finalists weigh in on various industry topics presented to them by Med Ad News.

December 5, 2016/by Andrew Humphreys

John Kamp: Trump administration promises change for health marketing

21st Century Cures Act, Biopharma, Biotechnology Innovation Organization (BIO), December 2016, Donald Trump, DTC, FDA, FDA/Regulatory, Issue Archives, John Kamp, PhRMA, Stocks, Supreme Court, Wall Street

Although virtually no one in the urban bubble where biopharmaceutical companies reside expected it to happen, Donald Trump won. So, now what?

December 5, 2016/by John Kamp

FDA Approves Opdivo for Head and Neck Cancer

Approvals, Clinical Trials, FDA, FDA/Regulatory, Health, Immuno-oncology, R&D, Squamous Cell Carcinoma

Bristol-Myers Squibb Co.’s immuno-oncology treatment Opdivo has now been approved in five tumor types in under two years by the U.S. FDA.

November 10, 2016/by Business Wire

How Scientific Affairs Can Assist Your Team with the FDA

Biologics, Center for Drug Evaluation and Research (CDER), CROs, FDA, FDA/Regulatory, Medical Devices, R&D

While acknowledging the many complexities of product development, sponsor teams should factor in these six guiding principles when planning programs for regulatory submission.

September 16, 2016/by Administrator

AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.

August 17, 2016/by Andrew Humphreys