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DTAB appoints committee to review fixed dose combinations
  • Khaitan & Co
  • India
  • February 19 2018

The Drugs Technical Advisory Board (DTAB) has reportedly appointed an expert committee under Ms Nilima Shirsagar, retired dean of Mumbai's KEM

Recreational cannabis in the workplace: A guide for California employers
  • Thompson Coburn LLP
  • USA
  • February 16 2018

Do your employees think they can smoke cannabis in the workplace because it’s legal? Are your employees telling you that even though they failed a

Opening Brief Filed in Deeming Rule Appeal by Nicopure Labs and the Right to be Smoke-Free Coalition
  • Keller and Heckman LLP
  • USA
  • February 14 2018

On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the Appellants) filed their opening brief in the appeal of last

White House Unveils Proposal on Drug Pricing
  • Holland & Knight LLP
  • USA
  • February 13 2018

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the

Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget
  • Cooley LLP
  • USA
  • February 13 2018

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals

FDA Drug Marketing Reports Due February 14, 2018
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 12 2018

On February 5, 2018, FDA released a reminder that NDA and ANDA holders’ one-time reports on marketing status under the FDA Reauthorization Act of 2017

FY 2019 President’s Budget - Health Care
  • Mintz Levin
  • USA
  • February 12 2018

Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. This is the first real budget of the

Da Volterra Develops Device to Combat Antibiotic Resistance
  • Knobbe Martens
  • USA
  • February 11 2018

Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product

Marijuana: Legal Framework in NJ for a Drug That is Illegal Under Federal Law: Reaction of US Attorneys to Rescission of Cole Memo
  • Porzio Bromberg & Newman PC
  • USA
  • February 6 2018

In the first part of our series, we outlined how the Department of Justice ("DOJ") during the Obama administration had provided specific guidance to

Food, Drug and Device Law Alert - FDA Makes Revisions to Two Medical Device Application Process Documents
  • Barnes & Thornburg LLP
  • USA
  • February 5 2018

The FDA recently issued two revised final medical device guidance documents titled, “Refuse to Accept Policy for 510(k)s” and“Acceptance and Filing