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Documents on pharmaceuticals
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|Off-Label Use: Protected Commercial Speech or Misbranding?|
David W. Ohlwein; Butler Snow LLP;
August 17, 2016, previously published on Spring 2016For years, the Food and Drug Administration has recognized that there is a prevalence of off-label use of drugs approved by FDA for specific indications, there is clinical relevance and value from such off-label use, and there is a large amount of information about both on- and off-label uses of...
|FDA Releases Draft Guidances on What Constitute "Essentially Copies" of Commercially Available or Approved Drug Products|
Duane Morris LLP;
August 17, 2016, previously published on August 4, 2016When Congress enacted the Drug Quality and Security Act in 2013, it provided that state-licensed pharmacies engaging in drug compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) could not “compound regularly or in inordinate amounts (as defined by the Secretary)...
|States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry|
Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 16, 2016, previously published on August 2, 2016As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of approximately a dozen bills that have been introduced in state legislatures over...
|FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests|
Jordan T. Cohen; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 15, 2016, previously published on July 21, 2016On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic products will be safe and effective.
|FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations|
Benjamin Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 15, 2016, previously published on July 22, 2016In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous year in 2009, 2010, 2013, and 2014, with 467 applications submitted in...
|FDA Reorganization Takes on Cancer Moonshot and Other Initiatives|
Eli Greenspan, Bethany Hills; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 15, 2016, previously published on July 15, 2016On July 11, 1969, the United States accomplished the almost unthinkable -two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State of Union Address. Vice President Joe Biden—who...
|Federal Circuit Decision Clarifies Application of On-Sale Bar to Third-Party Manufacturers and Suppliers|
Gregory A. (Greg) Castanias, Anthony M. Insogna, Randy Kay, Greg Lanier, David M. (Dave) Maiorana; Jones Day;
August 3, 2016, previously published on July 2016On July 11, 2016, in The Medicines Company v. Hospira, Inc., the Federal Circuit issued a rare unanimous en banc opinion addressing the circumstances under which a patentee's manufacturing and supply agreements with a third-party contractor could trigger the on-sale bar under 35 U.S.C. §...
|FDA Publishes Draft Guidance on Abuse-Deterrence Testing of Generic Solid Oral Opioid Drug Products|
Duane Morris LLP;
August 2, 2016, previously published on April 22, 2016On March 24, 2016, the U.S. Food and Drug Administration (“FDA”) published a draft guidance concerning studies for ANDA applicants to demonstrate the abuse deterrence of their generic solid oral opioid drug products. This draft guidance offers ANDA applicants principles for how to test...
|FDA Proposed Rule on Fixed-Combination and Co-Packaged Drugs|
Duane Morris LLP;
August 2, 2016, previously published on March 16, 2016The U.S. Food and Drug Administration (FDA) published its proposed rule on fixed-combination and co-packaged drugs, which relates to both prescription and over-the-counter (OTC) drug products and to combinations of active ingredients under consideration for inclusion in an OTC monograph. The...
|Blood Thinner Safety: What to Know When Taking Xarelto|
Law Offices of Peter G. Angelos A Professional Corporation;
July 26, 2016, previously published on July 6, 2016Blood clots have the ability to prevent blood flow to patients’ organs such as the heart, lungs, and kidneys, potentially causing stroke and other life-threatening health conditions. There are many different medications on the market today that aim to reduce the risk of dangerous health...