Regulatory and Washington

HDA releases 2 pilot studies in advance of Drug Supply Chain Security Act implementation
ARLINGTON, Va. — The Healthcare Distribution Alliance on Thursday presented two viable scenarios out of its Pilot Study for Saleable Returns, a study designed to help pharmaceutical manufacturers and distributors comply with requirements set forth by the Drug Supply Chain Security Act.
CRN's Supplement OWL goes live, now accepting product labels
WASHINGTON — The Supplement OWL (Online Wellness Library) is now accepting product labels from dietary supplement finished product manufacturers and marketers as the product registry moves into its phase two of beta-testing.

CRN celebrates 10-year anniversary of self-regulation initiative

WASHINGTON — The Council for Responsible Nutrition Foundation on Friday paid tribute during its annual conference in California to the 10-year anniversary of its partnership with the National Advertising Division on a self-regulatory advertising monitoring program that the Federal Trade Commission has called “an excellent example of self-regulation.”
Report: CDC director says Zika virus will become endemic to Fla.
GPhA outlines key GDUFA II goals at public meeting

WASHINGTON — On Oct. 21, the Food and Drug Administration held a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) II. At the meeting were various stakeholders, including the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, who outlined the goals of GPhA and the FDA in negotiations over the second iteration of GDUFA.
CDC makes available $70 million in supplemental Zika virus funding

ATLANTA - The Centers for Disease Control and Prevention on Friday announced the availability of about $70 million in supplemental funding to states, cities and territories to support continued efforts to protect Americans from Zika virus.
CHPA, CDC remind parents to keep medicines 'Up and Away' this Halloween

WASHINGTON - The Consumer Healthcare Products Association's Up and Away campaign, in partnership with the Centers for Disease Control and Prevention, is reminding parents to keep their medicines up and away and out of sight, especially during the Halloween season, as many children may mistake medicines for candy.
PaxVax announces Vaxchora cholera vaccine availability

REDWOOD CITY, Calif. — Vaxchora, the only Food and Drug Administration-approved cholera vaccine, is now available in the U.S., the vaccine maker, PaxVax, announced Monday.
Health Canada doesn't share FDA concern over homeopathic teething remedies

OTTAWA - Health Canada doesn't share the same concerns as the Food and Drug Administration when it comes to homeopathic teething remedies, the Canadian health agency announced Thursday.
CDC increases Public Health Emergency Preparedness funding

ATLANTA - The Centers for Disease Control and Prevention has increased by $44.3 million the Public Health Emergency Preparedness cooperative agreements for all-hazards preparedness efforts in 2016 and 2017. The funds will go to a total of 62 jurisdictions, including U.S. states, cities and territories.

HDA releases 2 pilot studies in advance of Drug Supply Chain Security Act implementation

CRN's Supplement OWL goes live, now accepting product labels

CRN celebrates 10-year anniversary of self-regulation initiative

Report: CDC director says Zika virus will become endemic to Fla.

GPhA outlines key GDUFA II goals at public meeting

CDC makes available $70 million in supplemental Zika virus funding

CHPA, CDC remind parents to keep medicines 'Up and Away' this Halloween

PaxVax announces Vaxchora cholera vaccine availability

Health Canada doesn't share FDA concern over homeopathic teething remedies

CDC increases Public Health Emergency Preparedness funding