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Prioritizing changes to patient information on over-the-counter (OTC) medications could significantly ease the regulatory burden on both the OTC industry and regulators, concludes a recent report by the Better Regulation of OTC Medicines Initiative (BROMI), a public and private coalition led by the Medicines and Healthcare products Regulatory Agency (MHRA).
The activist group that filed a lawsuit claiming political pressure from the White House and others forced the FDA to delay approving OTC sale of a controversial contraceptive is now urging the president to order the agency to approve the drug.
The activist group that filed a lawsuit claiming political pressure from the White House and others forced the FDA to delay approving OTC sale of a controversial contraceptive is now urging the president to order the agency to approve the drug.
A bipartisan bill seeking to improve the safety of OTC drugs and dietary supplements is out of committee and should easily pass the Senate, observers say.
A bipartisan bill seeking to improve the safety of OTC drugs and dietary supplements is out of committee and should easily pass the Senate, observers say.
Pfizer will sell its consumer healthcare division to Johnson & Johnson (J&J) for $16.6 billion and focus on developing new drugs and acquiring new technology, according to announcements by both companies.
The FDA’s recent letter rejecting a citizen petition for OTC sale of the controversial contraceptive Plan B is meant to be a legal broadside, heading off Plan B lawsuits by making clear how solid the agency’s legal footing is, a legal expert said.
Pfizer said it might sell off its consumer healthcare division, which includes 50 over-the-counter (OTC) products such as Neosporin, Listerine, Visine, Efferdent, Sudafed and Benadryl.
GlaxoSmithKline (GSK) moved one step closer to marketing it anti-obesity drug Xenical without a prescription after an FDA advisory panel overwhelmingly recommended the agency approve the company’s application to sell the drug OTC.
Nonprescription asthma inhalers should be removed from the market because they contain chlorofluorocarbons (CFCs) that harm the ozone layer, an FDA advisory panel has recommended.