Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Marshall, Gerstein & Borun LLP
The European Union is implementing new rules that will benefit generic pharmaceutical and biosimilar manufacturers,
BakerHostetler
FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation ...
BakerHostetler
Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.
Reed Smith
By now, the learned intermediary rule is so well established that new opinions addressing core learned intermediary issues, as opposed to applying the rule to specific fact patterns, are relatively uncommon.
BakerHostetler
The Second Circuit Court of Appeals breathed new life into a joint complaint by the Federal Trade Commission (FTC or Commission) and the state of New York against Quincy Bioscience,
Mintz
In our first two Device Modernization series posts, we discussed FDA's 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts
Hogan Lovells
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings ...
Arnold & Porter
In February 26, 2019, FDA published its long-awaited proposed rule, Sunscreen Products for Over-the-Counter Human Use (Proposed Rule).
Seyfarth Shaw LLP
Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case,
Orrick
As a pioneer in DNA synthesis with several patents to her name, Dr. Emily Leproust could have enjoyed a distinguished career without ever leaving the lab.
Oblon, McClelland, Maier & Neustadt, L.L.P
A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process ...
Jones Day
Manufacturers should be aware of, and prepare for, the actions FDA undertakes on its own initiative and as a result of the OIG recommendations.
Reed Smith
Our recent post on "wrinkle removal" – that is, removal before service – case got us thinking.
Reed Smith
Today's guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities that being informed speculation on what might be the consequences of a favorable Supreme Court
Ropes & Gray LLP
On January 1, 2019, the revised Code of Practice issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) went into effect.
BakerHostetler
Several Republicans appeared open to considering changes to patents, Medicare Part D and other policies.
Holland & Knight
Senate Finance Committee Chairman Charles Grassley (R-Iowa) has launched a new review of nonprofit hospitals, continuing a longstanding oversight in the sector.
BakerHostetler
Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.
Arnold & Porter
Consistent with FDA Commissioner Dr. Scott Gottlieb's and CDRH Director Dr. Jeffrey Shuren's efforts to modernize FDA's regulatory framework for medical technology software
STA Law Firm
This is a world rapidly changing with the new laws and regulations coming to play every day. With the new developments like Block Chain and AI ...
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Proskauer Rose LLP
On November 20, 2018, a years-long dispute before Judge Theodore Chuang in the District of Maryland over probiotics culminated in a gut-wrenching $18 million jury verdict against defendant pharmaceutical companies.
Reed Smith
Today's guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities that being informed speculation on what might be the consequences of a favorable Supreme Court
Reed Smith
Last week, in Timbs v. Indiana, ___ S. Ct. ___, 2019 WL 691578 (U.S. Feb. 20, 2019), the Court unanimously held that the Excessive Fines Clause of the U.S. Constitution's Eighth Amendment applies to the states:
Cooley LLP
That's because, in 2016, the House passed the Fostering Innovation Act of 2015—the very same bill.
STA Law Firm
This is a world rapidly changing with the new laws and regulations coming to play every day. With the new developments like Block Chain and AI ...
BakerHostetler
Several Republicans appeared open to considering changes to patents, Medicare Part D and other policies.
Reed Smith
Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices.
Orrick
As a pioneer in DNA synthesis with several patents to her name, Dr. Emily Leproust could have enjoyed a distinguished career without ever leaving the lab.
Arnold & Porter
In February 26, 2019, FDA published its long-awaited proposed rule, Sunscreen Products for Over-the-Counter Human Use (Proposed Rule).
Reed Smith
Our recent post about the First Amendment decision in American Beverage Ass'n v. City & County of San Francisco, ___ F.3d ___, 2019 WL 387114 (9th Cir. Jan. 31
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