News & Analysis as of

Request For Information Pharmaceutical Industry

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

Quarles & Brady LLP on

Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Foley Hoag LLP

Federal Regulators Examine the Role of Drug Supply Middlemen on Drug Shortages

Foley Hoag LLP on

The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more

Foley Hoag LLP - Medicaid and the Law

Gang of Six Introduces Historic 340B “Discussion Draft” Legislation

On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

McDermott+

McDermottPlus Check-Up: September 8, 2023

McDermott+ on

CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Barnea Jaffa Lande & Co.

ICA Request for Information: Foreign Company Fined

The Israeli Competition Director General recently announced he had reached an agreement with the British pharmaceutical company Leadiant Biosciences. According to the agreement, Leadiant undertook to pay ILS 110,000 to the...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #2

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

Latham & Watkins LLP on

PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

Epstein Becker & Green

Face or Fingerprint? The DEA Revisits Biometric Identifiers for e-Prescribing Controlled Substances

Epstein Becker & Green on

On April 21, 2020, the Drug Enforcement Administration (DEA) published a Request for Information (“RFI”) that reopened the comment period for an interim final rule that was published March 31, 2010 (75 FR 16236) (the “2010...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Hogan Lovells

Access to documents held by EMA: access requests by non-EU applicants to cease

Hogan Lovells on

The EMA has announced that, from 15 June 2018, the Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was a result of the high volume of access...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 1: Negotiated...

The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service,...more

16 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide