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Pharmaceutical Industry › Food and Drug Administration (FDA) › Public Meetings

Goodwin

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

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​​​​​​​On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more

Goodwin

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

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Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...more

Goodwin

FDA Schedules Public Meeting and Request for Comments on Biosimilar User Fee Act

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Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously...more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

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Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

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FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

Mintz - Consumer Product Safety Viewpoints

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Mintz - Consumer Product Safety Viewpoints on

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

Goodwin

FDA Advisory Committee to Hold Public Meetings on Amgen’s Proposed Bevacizumab Biosimilar and Mylan’s Proposed Trastuzumab...

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The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee...more

Goodwin

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

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As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Goodwin

FDA Advisory Committee to Hold Public Meeting on Hospira’s Proposed Epogen/Procrit Biosimilar

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The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer...more

McDermott Will & Emery

FDA Hosts Public Meeting on Off-Label Communications

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The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

Goodwin

FDA to Issue Draft Guidance on Interchangeability by End of Year

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Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates,...more

Fish & Richardson

FDA to Hold Public Meeting on Biosimilar User Fees

Fish & Richardson on

On September 13, 2016, FDA announced that it will hold a public meeting on October 20, 2016, from 9 a.m. to 2 p.m. at the FDA White Oak Campus in Silver Spring, Maryland, to discuss recommendations for the reauthorization of...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

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EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Goodwin

FDA Holds Public Hearing On Proposed Label Change Rule

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On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

McGuireWoods LLP

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

McGuireWoods LLP on

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

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