[ Price : $8.95]
FDA releases an FDA-483 issued following an inspection at Indias Unichem Laboratories drug manufacturing firm.[ Price : $8.95]
FDA releases 54 product-specific drug guidances to promote generic competition.[ Price : $8.95]
Two Kleinfeld, Kaplan and Becker attorneys analyze major medical device guidance documents issued in the first eight months of 201...[ Price : $8.95]
FDA proposes to amend its rules to require a single electronic format submission for medical device premarket filings, rather than...[ Price : $8.95]
FDA says it wants to change its public information regulations to incorporate Freedom of Information Act changes and make the proc...[ Price : $8.95]
FDA awards another round of pediatric device consortia grants to provide expert support to innovators of medical devices specifica...[ Price : $8.95]
FDA releases an FDA-483 with six observations from an inspection at Sun Pharmaceuticals Halol, India, manufacturing facility.[ Price : $8.95]
Federal Register proposed rule: FDA proposes to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product...