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
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
The FCA has issued the final version of its new anti-greenwashing rule – part of a package that includes additional rules as stage one of the UK’s new Sustainability Disclosure Requirements or SDR, plus the FCA’s new ESG...more
Following in the footsteps of its international counterparts, the Australian Prudential Regulation Authority ("APRA") is ramping up its guidance on the management of climate-related risks. On 22 April 2021, APRA released...more
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard...more
FSMA, Prop. 65 and Supply Chain Issues Among Subjects of Food Law Conferenc - In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) and...more
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more
On June 1, 2017, the state of New York’s Department of Economic Development (the department) issued draft forms and guidance to capture employee salary information from New York state contractors and subcontractors pursuant...more
President Obama’s Executive Order 13673, called the Fair Pay and Safe Workplaces Order, uses the prospect of gaining or losing an edge in winning government contracts to provide a powerful incentive for employers to comply...more
On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more