Recent Biotech, Cannabis, Food & Drug, & Pharma Administration News

Publication Date Organization
May
11
2015
 FDA Releases Draft Guidance on Using Clinical Data from Studies Conducted Outside the United States to Support Approval of Medical Devices Barnes & Thornburg LLP
May
11
2015
 Amarin Pharma Preemptively Sues FDA over First Amendment Rights Barnes & Thornburg LLP
May
8
2015
 Purdue Pharma v. Depomed: Denying Request for Rehearing Decision on Institution IPR2014-00379 Faegre Drinker
May
8
2015
 CMS Issues Interim Final Rule Reaffirming Requirements for Prescribers of Part D Drugs McDermott Will & Emery
May
7
2015
 CMS Amends Medicare Part D Program Integrity Regulations to Facilitate Beneficiary Access and Expand Coverage for Pharmacist Prescribers Epstein Becker & Green, P.C.
May
7
2015
 A Court in the Sunshine State Blocks Injunctive Relief against Neutrogena Sunscreen Claims; Meanwhile P&G Cannot Flush Charmin Claims for the Same Relief in New York Proskauer Rose LLP
May
7
2015
 340B ‘Mega-Guidance’ Arrives at Office of Management and Budget McDermott Will & Emery
May
6
2015
 Study Suggests Skin Cancer Drug May Help Treat Mesothelioma and Lung Cancers Steptoe & Johnson PLLC
May
6
2015
 FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions Covington & Burling LLP
May
6
2015
 Federal Circuit Keeps Sandoz Biosimilar Off The Market For Now Foley & Lardner LLP
May
5
2015
 Keeping Up With Kyle Bass: Pharma Patents Post Foley & Lardner LLP
May
1
2015
 FDA Finalizes Guidance Documents on Biosimilarity Sterne, Kessler, Goldstein & Fox P.L.L.C.
May
1
2015
 Onward to Trial: Federal Court Rejects Vermont’s Motion to Dismiss GMA Lawsuit Mintz
May
1
2015
 Petitioners Must Present Sufficient Evidence to Establish Inherency Mintz
Apr
30
2015
 Tomorrow is Another One-A-Day: FDA Guidelines Preempt Vitamin Claims, but Consumer Class Still Has Opportunity to Supplement Proskauer Rose LLP
Apr
30
2015
 Why the Grace Period Restoration Act Is a Bad Idea Foley & Lardner LLP
Apr
30
2015
 UPDATE: FDA Speeds Up the BMPEA Battle ArentFox Schiff LLP
Apr
30
2015
 FDA Finalizes Key Guidance Documents on Biosimilars Mintz
Apr
30
2015
 Galderma and Q-Med AB v. Allergan: Decision on Institution of Inter Partes Review IPR2014-01417 Faegre Drinker
Apr
29
2015
 FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions McDermott Will & Emery
Apr
29
2015
 German Federal Supreme Court Confirms Successor Liability for Coffee Roasters in Spite of Corporate Restructuring Covington & Burling LLP
Apr
28
2015
 Federal Government Study Shows Persistent Substance Abuse In U.S. Workforce Jackson Lewis P.C.
Apr
28
2015
 “Isolated” Natural Products Still in Purgatory Post-PTO Guidance?
Apr
28
2015
 New York Implements Medical Marijuana Rules Jackson Lewis P.C.
Apr
28
2015
 Approval of First Biosimilar Monoclonal Antibody in Brazil Michael Best & Friedrich LLP
Apr
27
2015
 Florida Governor Settles Litigation Over Drug Testing of State Workers Jackson Lewis P.C.
Apr
27
2015
 States Move to Impose Limits on Biosimilar Drug Substitution Mintz
Apr
27
2015
 Whistleblowers Get Second Chance in Altered Drug Case Mahany Law
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