Searching Content indexed under Food and Drugs Law by Akin Gump Strauss Hauer & Feld LLP ordered by Published Date Descending.
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Battle Lines Drawn With Release Of Speaker's Drug Pricing Plan
On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price negotiation and international reference pricing.
United States
8 Oct 2019
Drug Pricing And Surprise Billing: Recent Actions And Outlook
Recent months have seen a flurry of activity in Congress on prescription drug pricing and surprise medical bills as lawmakers seek to address rising consumer health care costs.
United States
9 Aug 2019
District Court Affirms FDA Policy On Compounding With Bulk Drug Substances—Bringing Much Needed Clarity For The Outsourcing Facility Industry
On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration's (FDA's) decision to exclude the bulk drug substance vasopressin
United States
8 Aug 2019
Podcast: CBD, THC, FDA – What You Need To Know About Cannabis And Its Regulation
In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD.
United States
25 Jul 2019
Supreme Court Strengthens Protection Of Confidential Business Information Submitted To Federal Agencies
Food Marketing Institute v. Argus Leader Media, decided June 24, 2019 by the Supreme Court, substantially expands the Freedom of Information Act exemption for confidential business information.
United States
4 Jul 2019
What's New In Washington - June 2019
The summer season has arrived in Washington and things are heating up in the halls of  Congress. A number of high priority legislative proposals ranging from health care
United States
21 Jun 2019
Checking In On FDA's Enforcement Discretion Policy For Laboratory Developed Tests
As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs),
United States
28 May 2019
The Federal Circuit Finds Jurisdiction Over The ITC's Decision Not To Institute An Investigation Under Section 337 And Explains When Claims Are Precluded By The FDCA
On May 1, 2019, a three-judge panel of the Court of Appeals for the Federal Circuit issued its long-awaited decision in Amarin Pharmaceuticals, Inc. v. ITC.
United States
22 May 2019
CMS Proposes Several Changes To Reimbursement For Transformative Medical Technologies
Currently, CMS bases new technology add-on payments on the cost to the hospital for the new medical technology.
United States
15 May 2019
New OMB Policy Will Likely Reduce Informal Agency Guidance
On April 11, 2019, acting director of the Office of Management and Budget (OMB) Russell Vought announced a policy for review
United States
7 May 2019
A Client's Guide To FDA Recalls
The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff ...
United States
29 Apr 2019
FDA Finalizes Criteria, And First Two Exclusions, For Outsourcing Facility Compounding With Bulk Drug Substances
Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations
United States
13 Mar 2019
Federal Circuit Decision Clarifies When An ANDA Filer May Appeal An Adverse IPR Ruling
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board ...
United States
31 Jan 2019
Updated: The Practical Impact Of The Government Shutdown For Private Parties
The new 116th Congress convened on Thursday, January 3, 2019 as the partial government shutdown, carrying over from the prior Congress, continued into the new year and has now outlasted previous shutdowns.
United States
23 Jan 2019
The Practical Impact Of The Government Shutdown For Private Parties
The new 116th Congress convened on Thursday, January 3, 2019 as the partial government shutdown, carrying over from the prior Congress, continued into the new year
United States
14 Jan 2019
The DQSA: Five Years In
November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law
United States
3 Dec 2018
What's New In Washington - September 2018
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30.
United States
5 Oct 2018
FDA Releases Revised Memorandum Of Understanding That Would Ease Restrictions On Interstate Shipment Of Compounded Drugs
On Friday, September 7, 2018, the FDA issued a lengthy press release detailing the agency's plans to collaborate with states in the oversight of traditional pharmacies engaged in drug compounding.
United States
12 Sep 2018
Federal Circuit Affirms That Tribal Immunity Is Not Available For Inter Partes Review
On July 20, 2018, the Federal Circuit affirmed in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals, Inc. that tribal immunity cannot be asserted in IPRs.
United States
13 Aug 2018
What's New In Washington - July 2018
Lawmakers returned from their Independence Day recess prepared for more legislative fireworks over a slew of outstanding agenda items, including a showdown over the Supreme Court...
United States
24 Jul 2018
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