Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Consumer Health Products Senior Editor
Washington DC, USA
17+ years of experience
HBW Insight
By Malcolm Spicer 19 Nov 2021
It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.
HBW Insight
By Malcolm Spicer 31 Oct 2021
While working to improve the quality of VMS products available in the US and to provide information on the products to consumers, the ODS doesn’t have authority to impose change on the industry or in the marketplace.
HBW Insight
By Malcolm Spicer 10 Sep 2021
Perrigo is the top potential marketer of the first OTC oral contraceptive in the US by acquiring HRA Pharma, which is preparing a switch NDA and earlier in 2021 gained UK regulatory approval for pharmacy sales of a progestin-only contraceptive, desogestrel.
HBW Insight
By Malcolm Spicer 13 Aug 2021
Rejection of two firms’ proposals for using hemp-derived CBD in supplement isn’t stirring US businesses selling CBD supplements to pull products from market. For one firm that filed an unsuccessful NDI notification for full-spectrum hemp extract CBD, FDA rejection was agenda item with numerous other business, regulatory and legislative developments in its latest quarter.
HBW Insight
By Malcolm Spicer 09 Jul 2021
Supplement OWL advisory board members Guru Ramanathan and Russ Michelson answer HBW Insight questions about the site’s progress and the potential for mandatory registration for dietary supplements sold in the US.
HBW Insight
By Malcolm Spicer 08 Apr 2021
NIH pays for 2m of Quidel's QuickVue tests in a program it’s conducting with CDC to determine whether frequent self-administered testing helps reduce community transmission of SARS-CoV-2.
HBW Insight
By Malcolm Spicer 29 Oct 2020
"One of the issues that COVID-19 has brought out is, how safe is the production of animal-based food products?" says Innova Market Insights North America executive Tom Vierhile at AHPA sports nutrition conference.
HBW Insight
By Malcolm Spicer 22 Jun 2020
FDA and FTC continue adding to total each has made during novel coronavirus pandemic. FTC's latest include peroxide gel and licorice as treatments; FDA’s emphasizes in warnings that three businesses' tests were not approved for OTC sales or for home use.
HBW Insight
By Malcolm Spicer 15 Jun 2020
While stockpiling for immune health support drove early sales growth in response to the pandemic, probiotic sales likely will continue increasing, says DuPont Nutrition probiotic marketing head Vanessa Bailey. “My gut tells me I think we could see some sustained increase. There’s going to be some difference in how we behave.”
Topic Coronavirus
HBW Insight
By Malcolm Spicer 17 Mar 2020
In addition to postponing NDAC meeting on food handler antiseptic drug products, FDA is suspending most inspections of foreign manufacturing facilities through April. Latest consumer health industry conferences cancelled or postponed are Consumer Healthcare Product Association and Informa Markets events.
Topic Coronavirus
HBW Insight
By Malcolm Spicer 27 Jan 2020
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
Topic Drug Review FDA OTC Drugs
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.
Topic FDA Legislation OTC Drugs
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.
Topic Dietary Supplements FDA
HBW Insight
By Malcolm Spicer 27 Nov 2019
Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.
Topic Dietary Supplements FDA Regulation
HBW Insight
By Malcolm Spicer 08 Nov 2019
"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.
Topic FDA Policy & Regulation
HBW Insight
02 Jun 2023
HBW Insight
01 Jun 2023
HBW Insight
31 May 2023
HBW Insight
30 May 2023
HBW Insight
30 May 2023
HBW Insight
26 May 2023
HBW Insight
25 May 2023
HBW Insight
24 May 2023
HBW Insight
23 May 2023
HBW Insight
22 May 2023
HBW Insight
21 May 2023
HBW Insight
18 May 2023
HBW Insight
17 May 2023
HBW Insight
16 May 2023
HBW Insight
12 May 2023
