WEEK OF MARCH 1, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress. […]
WEEK OF FEBRUARY 23, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress.
Since the beginning of 2024, our Trade Association professionals have seen an increase in scammers targeting persons who may be attending or have registered to attend trade association events such as meetings, shows, and conferences. These scammers email potential attendees and offer to sell, for a hefty cost, the attendee list and their contact information.
Association Events Targeted for Scams Read More »
WEEK OF FEBRUARY 16, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress.
WEEK OF FEBRUARY 9, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress.
WEEK OF January 29 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress. If
WEEK OF JANUARY 22 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up-to-date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the U.S. Congress. If
WEEK OF JANUARY 15, 2024 OFW’s Cannabis Team regularly monitors cannabis news, legislation, regulation, and policy so our clients stay up to date on the latest developments impacting their business. If you have any questions or would like more information about any of the items below, please contact us. We also track cannabis-related legislation introduced in the
As OFW Law’s Cannabis Team launches our new blog, CannaSweep, the team thought it would be helpful to explain what all is “swept” under the cannabis umbrella. For our first post, we describe what “cannabis” is and how it has found its way into agriculture, foods, cosmetics, drugs, and other commercial applications. It’s all Cannabis
As part of its ongoing enforcement against unlawful cannabis-containing foods and dietary supplements, the U.S. Food and Drug Administration (FDA) has recently posted two new Warning Letters against cannabis marketers: Both Warning Letters cite the marketers for promoting and distributing human and animal foods and dietary supplements containing (or that purport to contain) the cannabinoids
CBD AND DELTA-8 THC – UPDATE ON FDA ENFORCEMENT Read More »
The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation. The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions
FDA Announces a DSCSA Public Meeting and Requests Comments Read More »
On June 3, the Food and Drug Administration (FDA) released four guidances implementing the Drug Supply Chain Security Act (DSCSA). Final Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (Suspect Product Final Guidance) Final Guidance for Industry: Product Identifiers under the Drug Supply Chain Security Act – Questions
Long-Awaited DSCSA Guidances Published Read More »
President Biden recently issued an Executive Order (EO) to harness the federal government’s purchasing power to bolster domestic manufacturing. The “Strengthening Buy American Provisions, Ensuring Future of America is Made in America by All of America’s Workers” intends to support American industry and American workers. Overall, this EO looks to close loopholes in existing “Buy American” policies
How Does Buying American Benefit U.S. Food, Agriculture, and Medical Products? Read More »
This week, the Food and Drug Administration (FDA) announced release of a new guidance for immediate implementation that extends for another 3 years, until November 27, 2023, its enforcement discretion regarding verification of a prescription drug returns prior to resale. FDA also announced that it is delaying until November 27, 2023, its requirement that pharmacies
On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today! Learn what is expected of dispensers as it relates to the DSCSA through a HDMA webinar on Tuesday, April 21 from 2:00–3:00
Webinar: Drug Supply Chain Security Act Overview for Dispensers Read More »
The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation. 2015 promises to be equally busy. A Surge Of Activity At Year-End In 2014 2014 closed in a flurry of DSCSA action.
Drug Supply Chain Security Act – What’s Next? A whole lot. Read More »
In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other stakeholders have been working very hard to implement the DSCSA as quickly as
FDA’s Draft Guidance On DSCSA Preemption Misses The Mark Read More »
A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (DSCSA), beginning January 1, 2015, manufacturers, wholesaler drug distributors, and repackagers, must provide transaction data
Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act Read More »
While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules… FDA Opens Portal For Wholesale Distributor and 3PL Reporting At OFW Law, we hope you all had a terrific Thanksgiving. (If you followed the advice of our food safety expert, Dr. Barb Masters, there should not have been
FDA Opens Portal For Wholesale Distributor and 3PL Reporting Read More »
This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information. FDA is to be commended for both getting the Draft Guidance
The DSCSA Standards Guidance is here! Read More »
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, IV and V focus on
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, and III focused on Hatch-Waxman, medical
26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability Read More »
A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:
How to Legally Import and Market Pharmaceuticals in the U.S. and Canada Read More »
A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among
How to Legally Import and Market Pharmaceuticals in the U.S. and Canada Read More »
Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic drugs with labeling that “carves-out” information protected by a brand drug’s patents or marketing exclusivity. Section 505(j)(2)(A)(i) of the Food, Drug and Cosmetic Act requires that an Abbreviated New Drug Application (ANDA) contain “information to
Today, FDA announced that it has decided to reopen, for 60 days, the comment period for certain parts of its controversial final guidance, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND,” which was announced in the September 10, 2013 Federal Register. We blogged about the many
“Let food be thy medicine and medicine be thy food.” So Hippocrates, the father of medicine, stated. Unfortunately, the Food and Drug Administration (FDA) has taken Hippocrates too literally, with immediate and severe consequences to food and nutrition research in the United States. In September, FDA issued a final Guidance for Clinical Investigators, Sponsors, and
The FDA’s Final IND Guidance – A Bitter Pill for Food and Nutrition Research Read More »
In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration. Having passed the House of Representatives in September on a voice vote, the Senate overwhelmingly voted
FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC. FDA says Aegerion CEO, Marc Beer, on two separate occasions earlier this year, made off-label, unapproved claims, and failed to provide risk information. You
FDA Margin Call On Off-Label Promotion Read More »
With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surprising that the States have stepped up to fill the vacuum. One example is the State of
Bienvenue Aux Etats-Unis! Read More »
In 2012, identity theft was the number one complaint reported to the Consumer Sentinel Network. Protection of private consumer information continues to be a high priority for law enforcement and any business dealing with consumer information – that is, everyone – needs to keep abreast of what the Federal Trade Commission (FTC) is up to.
The FTC and Keeping Privacy Promises Read More »
In the 1984 film Ghostbusters, Dr. Egon Spengler declared to Janine Melnitz, “Print is dead.” A quick search of print is dead (electronic search, of course) reveals dozens of books and articles declaring that if traditional print communications are not actually deceased, they are decidedly on life-support. In pharmaceutical and healthcare regulation, electronic communications are
Not Dead Yet – The Paper PI Lives On Read More »
Today, the FTC adopted final amendments to the Children’s Online Privacy Protection Act (COPPA) Rule to increase privacy protections and give greater parental control over the personal information that websites and online services may collect from children under 13. A summary of the rule’s changes is here. The amended rules should be of interest to
FTC Releases Final COPPA Rule Read More »
The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday. As you can imagine, food preparation at a food and drug law firm is a very serious business. We regularly swap favorite turkey brining and stuffing recipes and
Compounding, Again Read More »
