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Generics Bulletin

Global Industry Hails Bioequivalence Progress

By Aidan Fry 11 Dec 2019

Article

For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.

HBW Insight

US Senate Passes First Monograph Reform Bill After House Passed Three

By Malcolm Spicer 11 Dec 2019

Article

Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.

HBW Insight

Fragrance Creators Association Readies New Consumer Website To Cap 'Year For The Public'

By Ryan Nelson 11 Dec 2019

Article

Farah Ahmed, president and CEO of the Fragrance Creators Association, discusses the trade group’s expansion in recent years beyond immediate regulatory and legislative concerns to a platform for robust member collaboration in the name of positively impacting the world.

Medtech Insight

Has EU Sorted Expert Panels As Tsunami Of 700 Applications Pour In After Extended Deadline?

By Amanda Maxwell 11 Dec 2019

Article

Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.

Pink Sheet

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

By Brenda Sandburg 06 Dec 2019

Article

Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.

HBW Insight

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

By Malcolm Spicer 06 Dec 2019

Article

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

HBW Insight

GSK Launches OTC Fluticasone In Japan Following Switch

By Tom Gallen 06 Dec 2019

Article

GSK has launched Flunase in Japan following the switch of fluticasone propionate. JSMI’s Toshi Tominaga gives his assessment of the product’s prospects as an OTC drug.

Generics Bulletin

Ophthalmics Are Next Frontier For Teligent

By Aidan Fry 06 Dec 2019

Article

US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.

Medtech Insight

Execs On The Move: New Research Chief At Biovica; Convergent Dental And XACT Robotics Find Sales VPs

06 Dec 2019

Article

Swedish cancer diagnostics firm Biovica International announces a new R&D director; Convergent Dental, a dental equipment company, and XACT Robotics, a robotics system developer, pick sales veeps; and more.

Topic Medtech

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