In Vivo is part of Informa PLC

This site 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.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Malcolm Spicer

Malcolm Spicer, Managing Editor – US

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.

Latest From Malcolm Spicer

US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance

The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.

Guidance Documents FDA

Included In Bausch’s Planned Spin-Off, Consumer Brands Account For 3 Spots In Its Top 10 List

Sales of its segment leaders Ocuvite and PreserVision vision health supplements, Lumify OTC eye drops and other consumer lines were down a reported 13% to $321m in the second quarter.

Commercial Consumer

With CBD Products Unlawful, FDA Enforcement Policy Guidance Has No Economic Significance

As draft guidance receives OMB review, FDA’s determination of no economic significance reflects its official position that the thousands of supplements, food and personal care products containing CBDs available in the US are unlawful.

Cannabidiol CBD Guidance Documents

US OTC Decisions In July: Labeling For Advil Sinus In 2-Count Packages, Lansoprazole, Ibuprofen

Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.

OTC Drugs Approvals

No Decisions Yet In Perrigo's Disputes With Ireland, US Over Tax Questions From Elan Merger

A court in Dublin has considered Perirrgo's challenge to Ireland tax authorities' ’ 2018 order to pay $1.9bn additional taxes from its 2013 acquisition of Elan that established it as an Irish firm. “We're just probably within 6 months now that we should get some kind of an answer in that regard,” says CEO Murray Kessler.

OTC Drugs M & A

US FDA Sets Rates For FSMA User Fees It Won’t Collect In FY 2021: Re-inspections, Recalls

Announcing rates for user fees authorized by Food Safety Modernization Act, FDA says supplement and food firms would be charged $263 an hour should agency officials need to re-inspect a US facility in FY 2021 and $310 an hour for facilities in other countries. Without a guidance for small businesses to request lower rates, the fees won't be imposed.

User Fees Dietary Supplements
See All
UsernamePublicRestriction

Register