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Searching Content indexed under Food and Drugs Law by Cooley LLP ordered by Published Date Descending.
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1
Mylan Settles SEC Charges For Disclosure And Accounting Failures Arising Out Of DOJ Investigation
At the end of September, the SEC announced that it had filed a complaint in federal court charging pharma Mylan N.V. with failing to timely disclose in its financial statements the "reasonably possible" material losses ...
United States
16 Oct 2019
2
Administration Releases Drug Importation Plan But Implementation Questions Abound
Under the HHS plan, there would be two importation methods.
United States
2 Aug 2019
3
White House Withdraws Rebate Rule
Earlier this morning, the White House announced that they were scrapping a proposed rule that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for ...
United States
15 Jul 2019
4
No Surprise! – Drug Pricing Legislation Picking Up Steam
Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress.
United States
21 Jun 2019
5
Nevada DHHS Releases 2019 Drug Transparency Report
The Nevada Department of Health and Human Services (DHHS) released today its 2019 Drug Transparency Report in connection with the state law requiring transparency related to essential diabetes drugs.
United States
4 Jun 2019
6
Medicare For All Unveiled In House. Some Things Old, Some Things New, But Much Left To Do
Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.
United States
18 Mar 2019
7
2018 Farm Bill Enacted With Important Provisions For Plant IP And Cannabis-Related Business
The $867 billion farm bill ("Agriculture Improvement Act" – House Res. 2) was signed into law by the president on December 20.
United States
23 Jan 2019
8
340B Drug Program Price Ceiling And Penalties Moved Up To Start January 1st
On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019 ...
United States
20 Dec 2018
9
OIG Provides Strong Rebuke Of Pharmaceutical Free Drug Program
On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General issued Advisory Opinion No. 18-14 regarding a proposed free drug program ("Proposed Arrangement").
United States
27 Nov 2018
10
Cooley Alert: Agreements Involving Biosimilars Must Be Reported To FTC And DOJ Under New Law
Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law.
United States
23 Oct 2018
11
Agreements Involving Biosimilars Must Be Reported To FTC And DOJ Under New Law
Consultation with antitrust counsel, both in structuring settlement agreements and in submitting filings, is therefore advisable.
United States
22 Oct 2018
12
HHS Releases Plan To Require Drug Makers To List Prices On TV Ads
Yesterday, the Department of Health and Human Services ("HHS") through the Centers for Medicare and Medicaid Services ("CMS") ...
United States
17 Oct 2018
13
Deal Or No Deal – Government Opens The (First) Box
The UK Government has been publishing technical notices, setting out its plans in the event that the UK and the EU fail to reach agreement before March 2019.
UK
10 Oct 2018
14
New Draft Guidance Regarding Data Sharing On Clinicaltrials.Gov And Civil Money Penalties
The FDA has the authority to impose CMPs of up to $11,569 for all violations of Section 402(j) adjudicated in a single proceeding.
United States
1 Oct 2018
15
CMS Releases Guidance Allowing Step Therapy For Part B Drugs
Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing "step therapy"
United States
14 Aug 2018
16
FDA Releases Draft Guidance Regarding Indications And Usage Section Of Drug Labeling
The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, "Indications and Usage Section of Labeling for Human Prescription Drug...
United States
24 Jul 2018
17
FDA Finalizes Two Guidance Documents Regarding Medical Product Communications
The FDA further stated that it the "ultimate goal is to help facilitate a market that is more competitive" and benefits patients.
United States
14 Jun 2018
18
FDA Issues First Of Four Draft Guidances Related To Patient-Focused Drug Development
Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1),...
United States
13 Jun 2018
19
Connecticut And Vermont Latest States To Pass Drug Pricing Transparency Bills
Following on the heels of several other states, including California, Nevada and Oregon, that have enacted drug pricing transparency bills, Connecticut and Vermont are the latest states to join the fray.
United States
11 Jun 2018
20
***UPDATED*** Senate ‘Right To Try' Bill Under Consideration In The House Of Representatives
The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right to Try' bill passed by the Senate in August 2017.
United States
23 May 2018
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