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Generics Bulletin
By Aidan Fry 11 Dec 2019
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
By Malcolm Spicer 11 Dec 2019
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
By Ryan Nelson 11 Dec 2019
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
By Amanda Maxwell 11 Dec 2019
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
By Brenda Sandburg 06 Dec 2019
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
By Malcolm Spicer 06 Dec 2019
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
By Tom Gallen 06 Dec 2019
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
By Aidan Fry 06 Dec 2019
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
06 Dec 2019
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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