Medical Device Legal News with Sam Bernstein: Episode 11
A few days ago, Corp Fin issued this guidance expanding the accommodations available for nonpublic review of draft registration statements to all issuers, building on the 2017 expansion of nonpublic reviews initiated by the...more
The Israel Securities Authority recently published a draft of a new directive for payment companies and holders of basic initiation licenses or approvals regarding reporting to the Authority. According to the Draft, payment...more
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more
Welcome to your weekly update from the Allen & Overy Pensions team, covering all the latest legal and regulatory developments in the world of workplace pensions. This week we cover the following topics : DWP General Levy...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
New Legislative Measures to Strengthen UK Corporate Reporting - On 19 July 2023, the draft Companies (Strategic Report and Directors’ Report) (Amendment) Regulations were laid in Parliament....more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more
On August 1, 2021, the US Senate unveiled the draft text of the Infrastructure Investment and Jobs Act (Bill), a highly anticipated $1 trillion infrastructure package negotiated by the White House and a bipartisan group of...more
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products...more
Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more
The Association of Air Pollution Control Agencies (“AAPCA”) submitted October 31st comments on the United States Environmental Protection Agency’s (“EPA”) Draft FY 2018 – 2022 Strategic Plan (“Plan”). EPA states the Plan...more
The U.S. Environmental Protection Agency (“EPA”) issued its Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce ( “Draft Guidance”) on May 16, 2017. See 82 Fed. Reg. 22452 (May 16,...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more
On August 26, 2015, the Section of Public Contract Law of the American Bar Association (“ABA”) submitted public comments to the General Services Administration (“GSA”) and the U.S. Department of Labor (“DOL”) on their...more
The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under...more
FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more