United States: FDA Releases Final Guidance On Use Of Digital Health...
As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December.
View ArticleUnited States: Marijuana: Top Ten Reasons For Descheduling, Rescheduling Or...
With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985...
View ArticleUnited States: CVM Relaxes Its Stance On Claims For Food Ingredient; Opening...
On Feb. 2, 2024, FDA's Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM).
View ArticleUnited States: FDA Issues Long-Awaited QMSR Final Rule - Hyman, Phelps, &...
More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule.
View ArticleUnited States: FDA Knows Its Own Strength—And It Includes Concentration -...
While the Biologics Price Competition and Innovation Act ("BPCIA") is inherently distinct from the Hatch-Waxman Act.
View ArticleUnited States: Surely You Must Be Kidding, PTO?!? "No, And Don't Call Me...
It's been a while since we last blogged on Patent Term Extension ("PTE") issues of interest. And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman...
View ArticleUnited States: FDA Flexes Its New FDORA Muscles In Withdrawing An Accelerated...
On Friday, February 23, 2024, FDA announced its final decision to withdraw the approval of Pepaxto (melphalan flufenamide), which was approved...
View ArticleUnited States: Keeping Your Company's Federal Contracting Options Safe In...
The most recent version of the BIOSECURE Act (the "Act") was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024.
View ArticleUnited States: One Step Closer To Final: The LDT Rule Arrives At OMB, Making...
FDA's proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards publication as a final rule – and to a likely judicial showdown.
View ArticleUnited States: Why, Who, When, Where And More: New Draft Guidance On...
On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C...
View ArticleUnited States: AstraZeneca's Challenge To Price Negotiation Fails In...
Last Friday, the Delaware District Court rejected AstraZeneca's lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS's guidance...
View ArticleUnited States: Traditional Meat Industry's Beef With Alternative Protein...
As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal...
View ArticleUnited States: ACI To Host Multiple Events Featuring HP&M Speakers –...
The American Conference Institute ("ACI") will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes.
View ArticleUnited States: How To Run DMC? It's Tricky – FDA's New Draft Guidance...
The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that revises the 2006 guidance...
View ArticleUnited States: 15 Years Strong: Rare Disease Week's Remarkable Journey Of...
In 2009—15 years ago— the National Organization for Rare Disorders (NORD) announced the first U.S. recognition of Rare Disease Day.
View ArticleUnited States: FDA Grants A Registration Fee Waiver For Very Small, Broke...
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts...
View ArticleUnited States: Bad Labs! Bad Labs? Whatcha Gonna Do? - Hyman, Phelps, & McNamara
On February 20, 2024, FDA issued a letter to the medical device industry (link) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in...
View ArticleUnited States: Drugs Companies Clap Back At Congress…Then Get Sued - Hyman,...
After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination...
View ArticleUnited States: Surely You Must Be Kidding, PTO?!? "No, And Don't Call Me...
After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. Patent and Trademark Office ("PTO") Patent Term Extension ("PTE")...
View ArticleUnited States: Feeling The Heat (Or Cold) – New Draft Guidance Addresses...
FDA recently issued a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (link), which describes information...
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